Total 3 Manager level Quality Assurance / Control job vacancies in Calow, Chesterfield, S44 5BL

To establish, develop and monitor the quality systems applicable to the pharmacy service with a particular focus on those relating to Manufacturing, Wholesale Dealing, Dispensary and other registered activity To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects etc. To undertake and support the preparation of SOP To ensure satisfactory maintenance and monitoring of the aseptic manufacturing unit and equipment To lead and co-ordinate internal quality audits (Production Unit and Stores and distribution) and external audits as required To ensure that appropriate validations are carried out including production and QC processes and that the resultant reports are written and distributed To approve written, or amended master worksheets, which relate to or might impinge upon licensable activities To set up technical agreements for outsourced service e.g. domestic services in compliance with GMP and QAAPS standards Responsible for organising regular QA/Production, QA/WDA and QA/Dispensary meetings to maintain Quality Assurance within the pharmacy and to monitor progress against internal and external inspections To be responsible for the internal procedures and policies relating to the release and rejection of materials by the Releasing Officers As a releasing officer, responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records. To be responsible for the approval or rejection of purchased unlicensed pharmaceuticals and for writing assessments for approval of suppliers. To evaluate Pharmacy manufacturing batch records, alongside Quality Control reports, prior to release or rejection of a batch To be responsible for the review and reporting of all microbiological testing results provided by Quality Control including consultations and discussions of action plans with the Production Manager if results are outside of recommended guidelines To embed quality risk management principles in all processes and documentation. This includes performing risk assessment in line with regulatory standards e.g. ICH, PIC/S, GMP To write, assess and evaluate tender specifications for services and equipment. To monitor outsourced services and escalate any deficiencies Ensure that key GMP records such as the site master file, validation master plan, control strategies and the quality manual is kept up to date and meets the needs of service users, in conjunction with regulatory, licensing and accreditation bodies. To support and where indicated lead investigations into deviations in quality processes To contribute to external inspection requirements relating to GMP and GDP eg MHRA , CQC , GPhC Ensure appropriate escalation of all risks and outstanding corrective and preventative actions Coordinate the investigation of relevant complaints in accordance with the complaints policy and procedure, in conjunction with service. Promote the provision of a customer centred approach in the provision of pharmacy services Liaise with service users through forums and surveys to establish views and opinions that will help to improve service standards. Provide monthly performance reports to the Pharmacy Quality Management Committee and Management Board Maintain relevant records, ensuring accurate data input into all computerised systems. To validate computerised systems (licensed activity only) to meet regulatory compliance Maintain an archive of all controlled documents in accordance with the data integrity requirements of regulatory, licensing and accreditation bodies, and in compliance with corporate policy and national legislation and guidance. Collect, interpret and present quality management data and statistics for use in monitoring the quality management system. Ensure robust systems are in place to develop staff, to ensure they can carry out their work safely and efficiently, working to the high standards demanded of the service, and providing evidence of competence assessment To manage the work of the Senior Pharmacy QA officer , ensuring that task are delegated appropriately Training To prepare and present tutorials and training sessions, both within the department, and externally as required To be responsible for the competency checks of Releasing officers and production staff and assessment prior to signing off training records To ensure that the Continuing Professional Development needs of the releasing officers are met To act as a mentor for Principal Department Leads across Pharmacy Monitor the review of training competences across the relevant parts of the pharmacy service, promptly reporting deficiencies to service managers as appropriate. Educate and train staff in quality principles and practice. Ensure that staff are adequately trained to understand and use the quality management system as relevant to their roles, and that training and competences are suitably documented and reviewed To assist in the design and provision of necessary commissioning of new production facilities and equipment To offer QA expertise and resources to other departments as required by the Trust To be responsible for the development and validation of new processes and methods in Quality Assurance and in the Production facilities. To maintain procedures and implement changes resulting from the updating of GMP and other regulatory standards and guidance documents To ensure the implementation of national and regional policies within Pharmacy To be named as the responsible person for Quality Control (Quality Controller) on regulatory MHRA manufacturers licenses as appropriate To be the Quality Control representative for Wholesale Dealing Activities. To represent Pharmacy Technical Service at CRH NHS Foundation Trust at internal development/management meetings, external regional meetings (East Midlands Technical Services Meetings) and nationally (National QA Symposium). Follow up on external inspections and verify the completion of corrective action as required by the inspectors reports in collaboration with service managers To contribute to the implementation of Quality Governance within the pharmacy service. To provide QA support into the operation of Clinical Trials in the department.

An excellent opportunity for a Compliance Manager to join a well-established company

Salary: Negotiable depending on experience
Benefits: Company bonus, pension and opportunities for personal developments

The Company:

They are a long-established and thriving family firm that designs, manufactures, installs and services cranes, goods lifts, fork-lift trucks, lighting winch systems and bespoke machinery for the nuclear decommissioning industry. Their products tend to be unique in the marketplace due to the deliberate strategy of finding innovative designs to solve customer problems. The past ten years has seen sustainability become a key driver for development with the company on track to be net zero within the next ten years. It is known internationally as a robust and prudently operated business with a proven commitment to customers, staff and suppliers. The company is a Royal Warrant holder as Engineers to Her Late Majesty the Queen.

As part of the Company’s commitment to working to the highest standards, they are looking for someone to lead the various management systems and ensure that we not only maintain compliance but continuously improve our processes and products. The successful candidate will work across all departments and support a wide variety of unique and high-quality projects for customers at home and abroad. The role will be supported through both their existing accredited management systems and the experienced colleagues and processes in place. Guidance and personal development can be given to the successful candidate for specific requirements.

Role and Responsibilities

• Upholding the following existing Management Systems:
• ISO 9001 – Quality Management
• ISO 14001 – Environmental Management
• EN 1090 – Factory Production Control / CE-Marking of Steel Structures
• EN 45001 - Occupational Health & Safety
• Work towards reporting greenhouse gas emissions in accordance with ISO 14064
• Leading the internal audit committee
• Coordinating external audits (including accrediting bodies, third party assessments, customers)
• Defining and monitoring of annual objectives
• Monitoring of supplier performance
• Compliance of company documents with appropriate legislation
• Maintaining legislative planned maintenance (LOLER, PUWER)
• Working with our third-party H&S advisory partner
• Maintaining COSHH register and risk assessments
• Coordinating calibration of appropriate items/equipment
• Upholding third-party approvals (e.g. Achilles, F4N) and completion of supplier questionnaires
• Assist with the completion of tender documentation
Candidate Requirements

• Experience working with and implementing BSI standards
• Ideally a formal engineering qualification
• Formal training in an area of quality, environmental or health & safety in the workplace NEBOSH preferable
• Relevant industrial experience preferable
• Ability to communicate ideas and reasonings to team members at all levels
• An interest and knowledge of machinery
• Fully proficient in Microsoft Office
• Willingness to learn new skills and expand existing knowledge
• Good verbal, visual and written communication skills
• Prepared to be flexible on working hours to meet deadlines
• A full driving licence that permits you to drive in the UK (unless reasonable adjustments can be made under the Equality Act 2010)
The successful candidate will be well supported by all members of staff but will be expected to meet deadlines from the outset and their performance will be monitored. The company has high expectations of all employees, and they are expected to continue with their personal development.

If you feel that you have the relative skills/attributes to fulfil this role then please apply now!

ARC are looking for a Head of Quality for our client based in Stoke Mandeville.

This is an exciting opportunities to work within a growing company. Our client is a precision engineering company based in Stoke Mandeville. They are a leading manufacturing company that specialises in producing high-quality precision parts and gears for aerospace , motorsport, and advance technology sectors. Their commitment to excellence, innovation, and customer satisfaction has earned them a reputation as a trusted and reliable partner.

Overall

As part of a dynamic team of quality inspectors in a bustling inspection lab, you will play a crucial role. Your daily routine involves active participation in meetings with senior leadership, collaborating to establish and prioritize daily tasks. You take charge of coordinating and managing the inspection team, ensuring smooth operations and timely delivery of our workload. Contribute to the daily inspections of parts and you actively oversee AS90111 quality audits.

Maintaining a well-organised department is key, and you lead initiatives such as 5S coordination. Additionally, you will contribute to and coordinate reports like PPAP, FAIR, and ISIR, ensuring accuracy and compliance.
Running Root Cause and Corrective Action (RCCA) processes is part of your responsibility to guarantee alignment with customer requirements.

In this role, you appreciate the autonomy for non-reviewed decision-making, allowing you to contribute effectively to the team's success.

Working hours Monday - Friday 08:00 - 16:30

Key responsibilities

• Lead manager and avcountable for the department
• Hands on nspection of components
• Quality scorecards and owner of departmental continuous improvement and SLT Rocks
• QMS compliance
• Audits
• RRCA
• Customer quality planning interface
• ECR updates quality processes
• Final sign off (PPAP/FAIR/ISIR)
• Staff 1-2-1 capability, training & development (qualification to world class status)
• Senior leadership team member

About you

• Bachelor's degree in engineering, quality management, or a related field (master's degree preferred)
• 5-8 years of experience in quality mangement, preferably in aerospace manufacturing or related industry
• Experience in developing and implementing a practical QMS tailored to smaller organizations
• Familiarity with quality tools and methodologies, with an emphasis on practical application
• Strong leadership and hands on management skills, with the ability to lead a small team effectively
• Excellent communication and interpersonal skills
• Knowledge of aerospace industry regulations and quality standards
• Problem solving skills and a commitment to pragmatic continuous improvement
• Relevant certifications, such as ASQ certified quality manager or similar (beneficial)
• Experience in leadership and people management demonstrated ability to handle multiple tasks and manage in a fast paced environment (beneficial)
• Familiarity with inspection methods (beneficial)
• Woking knowledge of applicable manufacturing and quality requirements including ISO 9001, AS9100 (beneficial)
• Proficient in the use of computers, bluepring reading, geometric tolerances GTD, and application of SPC to the manufacturing process (beneficial)
• Excellent interpersonal, communication, problem solving and an understanding of aerospace requirements (beneficial)

What's in it for you

• Competative salary
• 28 days holiday including bank holiday
• Loyalty bonus
• Health care
• Company benefits scheme
• Company pension contributions

If you are looking for a new environment, or a new challenge within an establsihed and expanding company. Apply with your CV.