Total 106 manufacturing production job vacancies in Australia

Please see attached job description for more information about this role and working at Royal Free London NHS Foundation Trust.

For more information on working for the Trust, please see the attached Job Description and Person Specification. For more details on the post, please contact Kerry Gratton on 01785 230242.

1. TECHNICAL RESPONSIBILITIES To manage and be responsible for all aspects of the day to day delivery of the production service ensuring that the service complies with all current regulatory requirements within designated rotation. Operating within bounds of COSHH, Health and Safety, GMP, GCP and QA regulations. To develop and maintain personal expertise in all technical aspects of manufacture ensuring his/her own accreditation for all appropriate tasks is maintained at all times. To develop and maintain all controlled documentation such as worksheets and standard operating procedures, in liaison with the Principal Pharmacists, Technical Services and Quality Assurance. To ensure that all relevant documentation is reviewed on a regular basis, updated as necessary and all out of date documentation is taken out of circulation. Ensure stock management of starting materials and final products and be responsive to market changes. To undertake the final product check, for batch products in which he/she has had no production involvement, prior to bonding and transfer to Quality Assurance testing. To ensure that no product is released for use in patients without undergoing the appropriate Quality Assurance process, where relevant. To ensure all quality exceptions and deviations from SOPs are reported to Quality Assurance, are appropriately documented and that resolution of the problem(s) is (are) undertaken in a timely fashion. Investigations are documented, in a timely manner, in accordance with the current practice and error reporting statistics are supplied to the national monitoring scheme. To ensure that all environmental monitoring is carried out, at the required time frequency, by appropriately trained staff. To ensure that regular broth fills, both by individual operators and for particular products are carried out at the required time. To ensure that the clean rooms are operating within specification prior to manufacture. To provide first pass engineering assessments for any facilities and equipment malfunctions. Implement and corrective and remedial actions prior to arranging visits to external contractors. 2. RESPONSIBILITY FOR COMMUNICATION To ensure that communication channels exist within the production unit so that staff at all levels are kept up to date with information that is appropriate with their role. To liaise with the dispensary, procurement and distribution departments and review procedures for requests, preparations and delivery of all products from the production unit to minimise waiting times. To communicate effectively with all users of the service. To chair weekly team meetings. To report all errors using internal reporting systems (EQMS/ Datix) and follow up with QA and relay information to Production staff for CAPA. To attend and contribute to all relevant meetings as required by the department leads e.g production meetings, departmental meetings, education and training. Create and support a culture of collaborative working between all areas of the department. Ensure good customer service culture for external and internal end users. To liaise with other senior staff members, ensuring the most efficient use of staff and facilities on daily and routine operational meetings. 3. RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT To support the Principal Pharmacists to determine which Specials medicines can be prepared within the capability of the unit. To be responsible, for the qualification, commissioning and validation of new manufacturing facilities and equipment and subsequent requalification activities. To ensure adequate procedures are written and staff training is carried out, to ensure safe operation. To ensure that the facilities and practices within the Pharmacy Manufacturing Unit meet the standards expected by the Medicines and Healthcare products Regulatory Agency (MHRA). To be present at MHRA inspections of the Trusts facilities and to provide appropriate documentation and answers to questions, as required. Join local and regional networks to support best practice. To undertake other duties as requested by the Principal Pharmacist, Technical Services. The Pharmacy Services of the Royal Free London are constantly evolving to best meet the needs of patients and our healthcare colleagues and partners and this may lead to providing a full and comprehensive pharmaceutical support over 7 days a week. Introduce change control to improve efficiency and quality of the manufacturing processes. 4. RESPONSIBILITY FOR FINANCIAL AND PHYSICAL RESOURCES To ensure accurate stock control is maintained in the Pharmacy Manufacturing Unit and for those items used in both Sterile and Non-sterile Production and that appropriate entries are made on the electronic dispensing system. To run daily stock take activities and rectify and discrepancies in a timely manner. To lead the annual stock-take for relevant area. To obtain quotes and service contracts for outside contractors services repair visits. Raise orders for payments of these services. To ensure timely booking out of materials and products on the electronic pharmacy system ensuring prompt release and inventory management. To ensure all written and computerised records are kept and maintained. Take active role in cost efficiency and waste reduction projects. 5. RESPONSIBILITY FOR LEADING AND MANAGING Complete all general management duties in line with trust policy. For example these will include: o To be involved in the recruitment and selection of full-time production staff and to ensure trust policies on recruitment are followed. o To monitor the performance of staff in their relevant rotations and identify any issues which the appropriate senior member of staff. o Conduct annual appraisal for direct line reports. o To approve annual leave requests for staff working in their relevant rotations, ensuring safe and adequate levels of experience at all times. o To conduct direct line report back to work health interviews for Production staff. To undertake the early stages of Trust personnel procedures such as excessive sickness review and performance and conduct review and maintain suitable records of performance and meetings undertaken within these processes. To liaise with the senior technicians in all areas of Pharmacy Production, together with the other Operations Chief Technician, to provide appropriate management cover, in their absence, to ensure the efficient and safe production of quality products. To oversee the running of the teams and assist/support in the absence of the senior technician. To ensure that communication channels exist within all areas of Pharmacy Production so that staff, at all levels, are kept up to date with information that is appropriate to their role. To ensure that regular staff meetings take place to ensure two way communications between junior staff and management. Ensure section KPIs are monitored and fulfilled on a monthly basis and provide data and support end of month reporting. Responsible for facilities and equipment management in those areas and co-ordinate maintenance and repairs with the trust estates department and external contractors including software systems in the areas. Management of the senior technicians and responsible for co-ordinating the staff within these areas ensuring manufacturing productivity. Organise and co-ordinate Planned Preventative Maintenance (PPM) programs and repair activities to limit downtime in the units. Ensuring there are always sufficient suitably experienced staff available to provide the necessary level of service. To produce the monthly batch production timetable for manufactured products. Distribute staff allocation/ rota according to accreditations and availability daily. Other relevant duties as assigned by the Chief Pharmacist, Principal Pharmacist or Deputy Production Manager. 6. RESPONSIBILITY FOR INFORMATION RESOURCES To work in strict compliance and accordance with MHRA guidance Note 14 The supply of unlicensed medicinal products specials. Ensure compliance with GMP, Good Distribution Practice (GDP), GCP and Falsified Medicines Directive (FMD) regulation and guidance. Operate under the quality management system and attend self-inspections with quality assurance team. To ensure compliance all other relevant legislation, national and local policies and procedures. e.g. The Medicines Act, Health and Safety at Work Act, etc is applied in Pharmacy Manufacturing Unit at all times. To uphold the principles of Clinical Governance within the trust.

1. To prepare and prioritise cancer chemotherapy and medicines for injection including GMO class 1 and 2, using laminar airflow cabinets or isolator technology, providing all necessary in-process checks, within the clean room environment under the guidance of good manufacturing practice. 2. To prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local trust policy and departmental procedures. 3. To work unsupervised if necessary in the preparation of cancer chemotherapy. 4. To follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice legislation and guidelines. 5. To prepare all types of product documentation, with all types of calculations and the production of labels using the Prisym 2000 label software. 6. To assemble the raw materials and consumables required to prepare each individual product, ensuring total segregation of each preparation using a box or tray segregation system as defined in the standard operating procedure. 7. To assist with Clinical Trial stock control to include the production and checking of routine stock checks, ensuring stock rotation and expiry date checks are completed and investigating stock discrepancies. 8. To complete, maintain and file all relevant documents, records and reports. 9. To clean the pharmacy aseptic suite and support rooms following standard operating procedures and using specific methods of cleaning, ensuring appropriate quality control samples are taken and cleaning logs filled out. 10. To co-operate and participate in any training and development in production services, attending such study days and courses as necessary for service development. 11. To complete any environmental monitoring or operator validation tests requested by the quality assurance manager as appropriate to Clinical Trials. To provide effective communication with the R&D department, the research team, multidisciplinary team and various UK organisations and pharmaceutical companies. 13. To undertake general dispensary duties, in accordance with standard operating procedures and the legal framework for the supply of medicines: Labelling - generate accurate medication labels Dispensing - accurately dispense inpatient, outpatient and discharge prescriptions, including clinical trials, cytotoxic drugs and controlled drugs. Issue drugs - to healthcare professionals referring for advice when necessary. In collaboration with the pharmacy clinical trials team to ensure accurate record keeping of drug accountability of all clinical trials (both written and computer records). Reporting any exceptions of deficiencies to the pharmacy clinical trials support manager. To contribute to the efficient stock control of all clinical trial products by undertaking regular stock checks to ensure sufficient (IMP/trial-specific) in date stock for current and new patients. To record clinical trial drugs returned by the patients on appropriate drug accountability records and dispose of them according to the trial. To assist in the close-down and archiving of completed clinical trials. Organise trial monitor visits ensuring that both the pharmacy site files are drug returns are prepared in advance. To respond quickly and appropriately to all enquiries and queries, directing to most appropriate team member. To use the pharmacy computer and related technologies according to the needs of the department. To participate in the ordering and receipt of clinical trials products following trial protocols, study specific instructions and the departmental SOPs. To ensure that all trials are run in accordance with GCP, Good Manufacturing Practice and Good Dispensing Practice guidelines/department procedures and reporting any deviations to the pharmacy clinical trials support manager. To monitor appropriate storage of all clinical trial products ensuring storage condition records and accurate expiry records for all clinical trial products are kept up to date and archived for future reference according to GCP, GMP Guidelines. To ensure that pharmacy trial store and equipment is kept in a clean and usable workable condition. To attend GCP training/sessions as appropriate and to work to GCP at all times. To participate in the appraisal process and to undertake appropriate mandatory training. To assist with training of the Pharmacy Assistant and other pharmacy staff as required in dispensing clinical trials. To participate in audit projects to review clinical trial processes. To contribute and assist with advice to pharmacy staff about clinical trials. To participate in the departmental training programme including NVQ Level II. To be able to adhere to Standard Operational Procedures and policies without supervision To participate and maintain a record of continuing personal and professional development.

Please refer to the JD/PD for full details on this post Please contact Sam Stone for further information or to arrange an informal visit samuel.stone@uhnm.nhs.uk 01782 674576

Undertaking the day-to-day activities required to ensure all deadlines are met and that work is completed according to written work instructions and Good Manufacturing Practice, Health and Safety at work act and any other legislation where applicable. Undertaking surface disinfection of raw materials and packaging components and passing into the aseptic suite, according to the WI, including undertaking initial and ongoing assessments of competence to undertake this duty. Labelling of manufactured products using dedicated computer-based labelling equipment under the direction of a suitably qualified member of staff, in accordance with written instruction sheets for each product. Undertaking daily, weekly and monthly cleaning duties within and outside the aseptic suite as directed by Senior Technician Production, including familiarity with spillage procedures and dealing with hazardous chemicals. Ensuring that pharmaceutical stock is stored with due regard to storage requirements and stock rotation, to include ambient, refrigerated, controlled drugs, unlicensed and hazardous items. Undertaking house keeping duties and stock checks of production area equipment and disposables, i.e. gloves, masks, syringes to ensure there are continuous supplies for use, according to established minimum levels.

You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.

Please see attached job description for more information about this role and working at Royal Free London NHS Foundation Trust.

Please refer to the JD/PD for full details on this post Please contact Sam Stone for further information or to arrange an informal visit samuel.stone@uhnm.nhs.uk 01782 674576

The candidate will work under Good Manufacturing Practice (GMP) guidance and be actively involved in aseptic preparation of chemotherapy, parenteral nutrition and clinical trials. Working with isolators and laminar airflow cabinets, utilising specialist equipment such as EM2400 Compounder for the preparation of parenteral nutrition. To apply and ensure the principles of Good Clinical Practice (GCP) are adhered to in managing clinical trials, maintain records of dispensing, including clinical trial material. To participate in the internal ordering, stock control and distribution of aseptic and clinical trial products. To assist in the instruction and supervision of pharmacy assistants, pre-registration pharmacy technicians, pre-registration and diploma pharmacists and pharmacy students To participate in the induction and supervision of new pharmacy staff To participate in staff performance and appraisal schemes and contribute to the staff training sessions. To participate in staff rotas including if necessary early and late sessions, weekend and bank holidays. To participate in departmental audits and service improvement initiatives Prioritises own work load and that of other junior colleagues working within the same area Ensure routine tasks are carried out within work area Ability to work within tight time frames and under pressure within a busy environment. Responds and manages changes in workflow priorities as the day develops Skill to dispense complex medications and to undertake manipulations with accuracy and speed. Works within standard operating procedures. To actively participate in the continual improvement of the pharmacy service Implement policies and propose changes to practices, procedures for own area Implements SOPs within pharmacy technician teams Actively participates in and maintains near miss and incident recording You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.

To ensure that all activities, documentation, and procedures within the unit meet current legislation such as GMP, GCP, Health and Safety and COSHH. To ensure and supervise the safe handling of cytotoxic, hazardous, and toxic materials. To be responsible for stock control for consumable items, drugs, and raw materials and the appropriate charging of all outgoing items. To assist the Chief Pharmacy Technician Production with the ordering of outsourced products including chemotherapy, TPN, and other Specials from commercial suppliers, and to ensure appropriate stock levels of these are maintained. To assist the Chief Pharmacy Technician Production, in collecting data for the Key Performance Indicators (KPIs) reports, and Quality Indicators (QIs). To assist in the internal and external audits of the aseptic service, and the subsequent approved action plans. To assist in the production aspects of clinical trials in liaison with the clinical trials team, and Good Clinical Practice (GCP). To prepare aseptic products within the isolator according to approved local SOPs, maintaining personal aseptic technique and validations. To promote and encourage reporting and learning from near-misses and errors within the service. To investigate errors in the unit, make recommendations and implement approved changes to practice in order to reduce the likelihood of reoccurrence. Please see the Job Description and the Persons Specification for further details about the job role.

You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.

Implement production policies which complies with Good Manufacturing Practice and current standards documents. To lead in the creation of user requirement specifications for manufacturing equipment. To select the contractors to provide the facility ensuring functional specification compliance with the user requirement specifications. To manage the new product introduction process including process validation. To assist in the development strategy to ensure a robust and fit for purpose manufacturing workforce. To manage contractors and to lead on the commissioning and qualification of facilities and manufacturing equipment. To manage the storage and distribution of manufactured medicines. To lead on the ongoing maintenance and re-qualification of the MMC facilities.

Work following SOPs at all times Production Checking, ensuring all BMRs and related production documents are completed prior to Quality Release. Production checking ensuring all manufactured items have been visually inspected Identification, investigation and documentation of deviations Identification and reporting of errors To ensure reports from customers relating to product quality complaints or adverse drug reactions are documented and the essential minimum information is collected and forwarded to the Regulatory Affairs Department the same day they are received. To deal with any other duties which do not change the nature of this post. To act in a professional manner at all times in order to promote a positive image of the Company.

To read more information about the advertised role, and the main job duties/responsibilities please open the Job Description and Person Specification located under the supporting documents heading. Informal enquiries and visits will be most welcome and to arrange this please contact Georgia Ascough, Lead Pharmacy Technician, on 01423 553088.