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Quality Systems Specialist
Eingestellt von Morgan McKinley
Gesuchte Skills: Support, Engineering
Projektbeschreibung
QUALITY SPECIALIST
POSITION SUMMARY
- Develop, Implement and maintain the Quality Management System to ensure that compliant and effective systems are established.
- The facility will encompass all steps to manufacture the finished product from incoming inspection of materials, manufacture of the finished product, sterilization, packaging and final testing/release to the distribution centres.
- The operation encompases clean room technology, critical utility systems, advanced automation technology and in house laboratory testing and release.
MAIN DUTIES AND RESPONSIBILITIES
- Development and introduction of key site quality systems as assigned:
- Document Management system
- Change control system
- Deviation process
- CAPA Process
- Management Review Process
- Supplier Quality
- Site Audit Readiness activities for both internal and external audits.
- Batch Record Review
- GxP Training
- SME for assigned quality systems providing ongoing guidance and direction to Associates at all levels in the organization.
- Work with a cross-functional and cross site team to develop and introduce electronic quality systems ie ETQ, Trackwise.
- Implement the Quality Management System.
- Conduct Staff Training as required.
- Resolve and assist in the closure of deviations/CAPA's/Complaints and follow up in the Quality System as required.
- Ensure that change requests and DCRs are compliant with all applicable procedures. This will involve actively reviewing the CR's and the underlying documents for compliance and the ability to be understood by third party reviewers. Responsible for providing feedback to the originators, approvers and site management.
- Support the development and implementation of quality reporting metrics.
- Track and trend key quality indicators and issue reports. Prepares presentations for Management Review Meetings.
- Conduct self inspections and external audits as appropriate.
- Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies/Plans, Batch Record updates, Validation documentation etc.)
- Update and maintain the Approved Supplier List. Approve Suppliers and materials/services as required.
- Conducts/participates in supplier audits. Works with suppliers to ensure corrective action plans are developed and implemented for non-conformances identified.
- Assess requirement for and Develop Quality Agreements/Commitments.
- Lead Supplier Review Board.
- Provide training in all aspects of Quality Management Systems and GMP.
- Provide support and advice during cross functional investigations/projects and as required.
- Drives the continuous improvement of the key Quality System processes.
- Define and Implement the Batch Release Process.
- QA Input for all Process Development and production related activities.
- Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
KEY SKILLS AND COMPETENCIES REQUIRED
- Proficiency in applicable GMP/QSR regulations.
- Ability to prioritize and manage the workload, and as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
Demonstrate excellent communication skills (verbal and written). - Ability to develop and give presentations on technical and regulatory topics.
- Ability to train/mentor associates.
- Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
- Ability to read, analyze, and interpret complex technical documents and manuals
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
EDUCATION AND EXPERIENCE
- Minimum qualification B.Sc or M.Sc/M.Eng Degree in one of the following disciplines: Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline
- 5 Years minimum post educational experience with working in a regulated environment preferably within a Pharma/Biotech facility
- Knowledge of EU/US quality related Biological/pharmaceutical/Medical Device regulations.
- Understanding/experience with a process and utility plant start-up would be an advantage
Good level of computer literacy required. - Statistical Analysis competency required.
POSITION SUMMARY
- Develop, Implement and maintain the Quality Management System to ensure that compliant and effective systems are established.
- The facility will encompass all steps to manufacture the finished product from incoming inspection of materials, manufacture of the finished product, sterilization, packaging and final testing/release to the distribution centres.
- The operation encompases clean room technology, critical utility systems, advanced automation technology and in house laboratory testing and release.
MAIN DUTIES AND RESPONSIBILITIES
- Development and introduction of key site quality systems as assigned:
- Document Management system
- Change control system
- Deviation process
- CAPA Process
- Management Review Process
- Supplier Quality
- Site Audit Readiness activities for both internal and external audits.
- Batch Record Review
- GxP Training
- SME for assigned quality systems providing ongoing guidance and direction to Associates at all levels in the organization.
- Work with a cross-functional and cross site team to develop and introduce electronic quality systems ie ETQ, Trackwise.
- Implement the Quality Management System.
- Conduct Staff Training as required.
- Resolve and assist in the closure of deviations/CAPA's/Complaints and follow up in the Quality System as required.
- Ensure that change requests and DCRs are compliant with all applicable procedures. This will involve actively reviewing the CR's and the underlying documents for compliance and the ability to be understood by third party reviewers. Responsible for providing feedback to the originators, approvers and site management.
- Support the development and implementation of quality reporting metrics.
- Track and trend key quality indicators and issue reports. Prepares presentations for Management Review Meetings.
- Conduct self inspections and external audits as appropriate.
- Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies/Plans, Batch Record updates, Validation documentation etc.)
- Update and maintain the Approved Supplier List. Approve Suppliers and materials/services as required.
- Conducts/participates in supplier audits. Works with suppliers to ensure corrective action plans are developed and implemented for non-conformances identified.
- Assess requirement for and Develop Quality Agreements/Commitments.
- Lead Supplier Review Board.
- Provide training in all aspects of Quality Management Systems and GMP.
- Provide support and advice during cross functional investigations/projects and as required.
- Drives the continuous improvement of the key Quality System processes.
- Define and Implement the Batch Release Process.
- QA Input for all Process Development and production related activities.
- Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
KEY SKILLS AND COMPETENCIES REQUIRED
- Proficiency in applicable GMP/QSR regulations.
- Ability to prioritize and manage the workload, and as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
Demonstrate excellent communication skills (verbal and written). - Ability to develop and give presentations on technical and regulatory topics.
- Ability to train/mentor associates.
- Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
- Ability to read, analyze, and interpret complex technical documents and manuals
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
EDUCATION AND EXPERIENCE
- Minimum qualification B.Sc or M.Sc/M.Eng Degree in one of the following disciplines: Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline
- 5 Years minimum post educational experience with working in a regulated environment preferably within a Pharma/Biotech facility
- Knowledge of EU/US quality related Biological/pharmaceutical/Medical Device regulations.
- Understanding/experience with a process and utility plant start-up would be an advantage
Good level of computer literacy required. - Statistical Analysis competency required.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges