Total 23 job vacancies by Mp Biomedicals Asia Pacific Pte. Ltd.

Basic Functions:

• Assist in maintaining company’s compliance to quality management system established.
• Responsible in monitoring the calibration and maintenance program.
• Ensure that ISO 13485, In-vitro Diagnostics Directive 98/79/EC, IVDR 2017/746 and 21 CFR Part 820 Quality System Requirement, MDSAP (Medical device Single Audit Program) are properly implemented and maintained at all levels.
• Establish and maintain proper document archiving and control system.

Duties:

• Assist in maintaining company’s compliance to quality management system established.
• Assists in internal and external audits.
• Responsible in handling the corrective and preventive action system and its sub-system (i.e. Nonconforming product and internal audit).
• Ensure that proper document control procedure and system is implemented for Product Specifications, Operation Manuals, Standards, Drawings and all quality related documents.
• Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Together with the Documentation Center, ensure that all documents submitted and/or generated are archived.
• Co-ordinate, review, collate, update and issue all quality-related documents to relevant personnel.
• Prepare necessary documentation (e.g. Certificate of Analysis and Certificates of Origin) to support shipment of products overseas.
• Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Ensure that all documents submitted and/or generated are archived.
• Receive Production / QC Records and all quality related documents and ensure that proper document archiving and control system is implemented.
• Ensure that all documents submitted and/or generated are archived.
• Compile and ensure that the Quality Records Master List is updated.
• Perform other duties as assigned.
• Support the projects of material qualification
• Any other duties as and when assigned.

Minimum qualification Requirements

Ability to:

• Demonstrate the use of all equipment, materials, and techniques relevant to job performance, execute and maintain pertinent validation protocols as required and maintain quality standards.
• Establish quality assurance system and undertake systems / product / process validation

Knowledge of: Various quality control/process control requirements, quality management system and documentation relating to biomedical and /or IVD products. Technical terminology used in the laboratory, assigned scientific techniques and knowledge of QC procedures governing a number or basic laboratory operations.

Education: Basic Science Degree

Experience: No prior working experience is required for Executive position. At least 3 years of relevant working experience for Senior Executive position.

Basic Functions:

Leads a project for assay design and developments, co-ordinate stability studies and marketing supports (trouble shooting assays).

Duties:

• Plan and conduct experiments according to project plans and keep timelines
• Design and conduct investigations and experiments, record and analyze or interpret the results in support of project development objectives, keep accurate records of work undertaken
• Supervise and support other team members in planning and execute experiments
• Follow standard operating procedures and safety guidelines and maintain a clean and orderly environment
• Engage in continuous learning and skill development
• Maintains and implement ISO 13485 / FDA QSR 21 CFR: PART 820 and other relevant International standards and regulations
• Communicate and collaborate with other professionals in the lab
• Ensure necessary and effective support for operations and marketing on technical issues, customer special requirements, complaint and problem solving
• Assist new product clinical trials and new product transfer and provide necessary supports such as developing procedures and standards for product launching
• Conduct initial review for study protocols & reports and other documents to support R&D projects prior to external review
• Identify process problems, suggests improvements, and initiates trouble-shooting.
• Provide adequate and appropriate training for subordinates
• Assist with lab planning and equipment calibration and maintenance
• Other projects as assigned by department manager

Requirements:

– Ability to: Lead a project team in carrying out the task.

– Knowledge of: : Immunodiagnostics, microbiology

– Education: PhD; MSc/MEng; Good Honors degree; or equivalent.

– Experience: At least 2-6 years of relevant work experiences

Basic Functions:

• Carries out product development related activities and supports to stability studies, trouble shooting, customer complaints and other special requirements.

Duties:

• Carries out experiments, assays as assigned by the project leader.
• Complies to the ISO 13485 / FDA QSR 21 CFR: PART 820 standards for the Research & Development laboratory.
• Prepares study protocol, conducts experiments and provides data for new products or reports in supporting operation and marketing on technical issues, customer special requirement, complaint and problem solving.
• Generates necessary documentation for procedures and standards for product development and launching.
• Provides supports to stability studies by carrying out assays and producing reports as assigned by the Research Scientist and Manager.
• Other projects/tasks assigned by the Department Head and project leader.

Requirements:

Ability to : Plan and carry out experiments

Knowledge of : Immunodiagnostics and Biomedical Sciences

Education : BSc or equivalent

Experience : 2 years of relevant working experiences preferred but not essential

Basic Functions:

• Assist in maintaining company’s compliance to quality management system established.
• Responsible in monitoring the calibration and maintenance program.
• Ensure that ISO 13485, In-vitro Diagnostics Directive 98/79/EC, IVDR 2017/746 and 21 CFR Part 820 Quality System Requirement, MDSAP (Medical device Single Audit Program) are properly implemented and maintained at all levels.
• Establish and maintain proper document archiving and control system.

Duties:

• Assist in maintaining company’s compliance to quality management system established.
• Assists in internal and external audits.
• Responsible in handling the corrective and preventive action system and its sub-system (i.e. Nonconforming product and internal audit).
• Ensure that proper document control procedure and system is implemented for Product Specifications, Operation Manuals, Standards, Drawings and all quality related documents.
• Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Together with the Documentation Center, ensure that all documents submitted and/or generated are archived.
• Co-ordinate, review, collate, update and issue all quality-related documents to relevant personnel.
• Prepare necessary documentation (e.g. Certificate of Analysis and Certificates of Origin) to support shipment of products overseas.
• Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Ensure that all documents submitted and/or generated are archived.
• Receive Production / QC Records and all quality related documents and ensure that proper document archiving and control system is implemented.
• Ensure that all documents submitted and/or generated are archived.
• Compile and ensure that the Quality Records Master List is updated.
• Perform other duties as assigned.
• Support the projects of material qualification
• Any other duties as and when assigned.

Minimum qualification Requirements

Ability to:

• Demonstrate the use of all equipment, materials, and techniques relevant to job performance, execute and maintain pertinent validation protocols as required and maintain quality standards.
• Establish quality assurance system and undertake systems / product / process validation

Knowledge of: Various quality control/process control requirements, quality management system and documentation relating to biomedical and /or IVD products. Technical terminology used in the laboratory, assigned scientific techniques and knowledge of QC procedures governing a number or basic laboratory operations.

Education: Basic Science Degree

Experience: No prior working experience is required for Executive position. At least 3 years of relevant working experience for Senior Executive position.

Basic Functions:

Perform the administrative role to support the Human Resources & Administrative functions.

Duties:

Provides day to day support in full spectrum in HR & Administrative functions but not limited to the following:

• Prepare the monthly Payroll (headcount: 100 to 150)
• Preparation of statutory submission such as CPF and IRAS
• Administration of NS make-up pay, Maternity, Childcare, Paternity Leave, Wavier of Levy claims
• Administer HRMS (Payroll, leave, attendance, bio-metric)
• Manage the employee on-boarding and off-boarding processes
• Organize, maintain and filing of personnel records of employee in P-file
• Responsible for end to end recruitment activities.
• Maintain good filing system.
• Arranges corporate travel for all personnel.
• Provides assistance to organizing/planning of corporate events and activities.
• Oversees all office administrative matters including but not limited to procurement of office/pantry supplies, vendor management, etc.
• Assist and manage any other ad-hoc duties assigned from time to time.

Requirements:

Diploma in Human Resources Management or Business Administration

Minimum 2 years of relevant HR working experience with payroll handling.

Basic Functions:

• Carries out product development related activities and supports to stability studies, trouble shooting, customer complaints and other special requirements.

Duties:

• Carries out experiments, assays as assigned by the project leader.
• Complies to the ISO 13485 / FDA QSR 21 CFR: PART 820 standards for the Research & Development laboratory.
• Prepares study protocol, conducts experiments and provides data for new products or reports in supporting operation and marketing on technical issues, customer special requirement, complaint and problem solving.
• Generates necessary documentation for procedures and standards for product development and launching.
• Provides supports to stability studies by carrying out assays and producing reports as assigned by the Research Scientist and Manager.
• Other projects/tasks assigned by the Department Head and project leader.

Requirements:

Ability to : Plan and carry out experiments

Knowledge of : Immunodiagnostics and Biomedical Sciences

Education : BSc or equivalent

Experience : 2 years of relevant working experiences preferred but not essential

Duties

• Design, development, building and qualifying of various lab instruments, the major focus on Sample Preparation equipment including our featured FastPrep family (homogenizer).
• Develop and fabricate test equipment in-line with test specifications under the direction and guidance of direct supervisor.
• Execute tests using test equipment that measures temperature, electricity, light, flow, pressure, strain, force, distance, time, noise, weight etc.
• Collect and analyze test data/results, document results and outcomes.
• Support the design and fabrication/assembly of both working and visual prototype models.
• Analyze equipment failures and factory work stoppage problems and provide solutions.
• Fabricates, repairs, improves designs and constructs electro-mechanical equipment.
• Coordinate with external vendors effectively for fabrication and OTS parts procurement.
• Maintains detailed and up to date test data in laboratory notebook and active test logs.
• Support manufacturing ramp up, and design transfer during product development.

Requirement:

• Master's Degree and above in Electrical Engineering or Mechanical Engineering
• 5 years of hands-on Mechanical and Electrical experience.
• Possess broad base of knowledge with understanding and skills in the following areas: Electrical, Electronics, Fabrication, Tool Making, Machining.
• Must be proficient in the use of all hand tools including saws, drills, grinders and other tools.
• Able to operate test equipment that measures temperature, electricity, light, flow, pressure, strain, force, distance, time, noise and weight.
• Can work from prints, sketches, written and verbal instructions.
• Reads wiring/electrical and piping schematics and engineering drawings.
• Electrical experience/training in use of and design of AC and DC circuits.
• Ability to use electrical test equipment and measuring tools necessary.
• Self-motivated, team player with excellent communication and problem solving skills.
• Experience and knowledge of the following areas preferred:

- Rapid Prototyping

- Testing and Design Controls

- Installation

- Design

Basic Functions:

– Acquisition & Merger Activities

– Assume overall responsibility for corporate business development activities of MP’s diagnostic & life science products

– Executive member of the Strategic Planning Team to develop short & long term business objectives & strategies

– Business development budgets

– Identify and evaluate new markets for significant growth of the company’s range of diagnostic & life science products

– Seek collaboration with research institutions and commercial organizations for tie-ups including acquisitions, licensing of technologies, contract manufacturing, contract research, joint product development, & product commercialization.

– Introduction of new products & technology to the company through OEM, OBL, PLM, CR/CM partnerships

– Keep abreast of developments in the industries in in-vitro diagnostics testing, life science, biotechnology, biomedical science & healthcare, and to update the company personnel on these industries and technological trends which are of relevance

– Lead organizational projects to improve business model as in setting up of regional manufacturing facilities & promoting their products

– Analyze and assess the relevant public policies related to MP’s business interests. Communicate and interact with the external stakeholders and drive the implementation activities.

Duties:

– Identify and perform due diligence of companies for potential acquisition & merger

– Identify new products and technology for introduction to MP under OEM, OBL, & PLM partnerships

– Review agreements pertaining to all business development activities

– Prepare and achieve business development budget

– Develop & implement strategies for the organization in generating new businesses through new products & technology, new markets & acquisition

– Governmental relationship development and maintenance

Requirements:

Ability to: Demonstrate high degree of leadership, teamwork, interpersonal skills and ability to work with minimal supervision.

Knowledge of: Sales & marketing management, and business development in relevant products knowledge.

Education: MSc/PhD degree

Experience: 5 - 8 years’ experience in sales & marketing and/or business development in diagnostics (eg. infectious diseases testing market, diagnostic test kits, instrumentation and related products) and/or life science products (eg. Molecular biology, immunology, cell biology, biochemicals). International sales and marketing and/or business development experiences in USA, Latin America, Europe, Middle-East, Africa & Asia will be an added advantage.