Quality Specialist(Qualified Person)- Ethicon Biosurgery-00000FT3
Description
Position Title: Quality Specialist
Department: Quality
Report to: QA Manager
Location: Limerick
Travel: 5 - 10%
Global Compensation Framework Band Number: 25
Company Summary:
Ethicon BioSurgery Ireland, Division of Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions. The start-up manufacturing operation located at the national technology park Limerick, consists of the development of a new advanced manufacturing plant with the capability to manufacture and release worldwide supply for a revolutionary surgical Fibrin Sealant Patch called EVARREST™.
EVARREST™ Fibrin Sealant Patch, is a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery. EVARREST™ consists of a coating of biologics and a flexible patch that, when combined, form a distinct delivery system that will raise the standard of care for surgeons and their patients.
The manufacturing facility in Limerick 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.
Position Summary:
Quality Specialist will support the Fibrin Sealant Patch QC Laboratory and supplier quality process. Develop and Implement key Quality systems in a start-up facility ensuring that compliant and effective systems are established.
Main duties and responsibilities:
• Provide QA support to the QC Laboratory function (Microbiology, Biochemistry, Chemistry).
• Support preparation, review, approval and execution of Equipment/Instrument qualification.
• Support preparation, review, approval and execution of Test Method Transfer/Verification.
• Resolve and assist in the closure of discrepancies initiated during qualification/test method transfer.
• Resolve and assist in the closure of OOS’s.
• Approval of all QC procedures, specifications, sampling plans and risk Assessments.
• Work with a cross-functional and cross site team to develop and introduce electronic quality systems i.e. LIMS, Trackwise.
• Oversight of SQ program – inclusion and implementation of process/policy/ procedures/Forms.
• 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.
• Establish Supplier Performance Monitoring.
• Development and introduction of key site quality systems as assigned:
o Management Review Process
o Site Audit Readiness activities for both internal and external audits.
• Conduct self inspections and external audits as appropriate.
• Provide training in all aspects of Quality Management Systems and GMP.
• Provide support and advice during cross functional investigations / projects and as required.
• Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies / Plans etc.)
• Drives the continuous improvement of the key Quality System processes.
• Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
• May be required to work a shift system in accordance with the operational needs of the business.
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.
Qualifications
Education and Experience:
• Minimum qualification B.Sc Degree in one of the following disciplines: Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline.
• QP qualification is essential.
• 6 Years or more post educational experience 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 Laboratory/ plant start-up would be an advantage.
Primary Location:Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Quality (Generalist)
Description
Position Title: Quality Specialist
Department: Quality
Report to: QA Manager
Location: Limerick
Travel: 5 - 10%
Global Compensation Framework Band Number: 25
Company Summary:
Ethicon BioSurgery Ireland, Division of Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions. The start-up manufacturing operation located at the national technology park Limerick, consists of the development of a new advanced manufacturing plant with the capability to manufacture and release worldwide supply for a revolutionary surgical Fibrin Sealant Patch called EVARREST™.
EVARREST™ Fibrin Sealant Patch, is a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery. EVARREST™ consists of a coating of biologics and a flexible patch that, when combined, form a distinct delivery system that will raise the standard of care for surgeons and their patients.
The manufacturing facility in Limerick 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.
Position Summary:
Quality Specialist will support the Fibrin Sealant Patch QC Laboratory and supplier quality process. Develop and Implement key Quality systems in a start-up facility ensuring that compliant and effective systems are established.
Main duties and responsibilities:
• Provide QA support to the QC Laboratory function (Microbiology, Biochemistry, Chemistry).
• Support preparation, review, approval and execution of Equipment/Instrument qualification.
• Support preparation, review, approval and execution of Test Method Transfer/Verification.
• Resolve and assist in the closure of discrepancies initiated during qualification/test method transfer.
• Resolve and assist in the closure of OOS’s.
• Approval of all QC procedures, specifications, sampling plans and risk Assessments.
• Work with a cross-functional and cross site team to develop and introduce electronic quality systems i.e. LIMS, Trackwise.
• Oversight of SQ program – inclusion and implementation of process/policy/ procedures/Forms.
• 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.
• Establish Supplier Performance Monitoring.
• Development and introduction of key site quality systems as assigned:
o Management Review Process
o Site Audit Readiness activities for both internal and external audits.
• Conduct self inspections and external audits as appropriate.
• Provide training in all aspects of Quality Management Systems and GMP.
• Provide support and advice during cross functional investigations / projects and as required.
• Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies / Plans etc.)
• Drives the continuous improvement of the key Quality System processes.
• Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
• May be required to work a shift system in accordance with the operational needs of the business.
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.
Qualifications
Education and Experience:
• Minimum qualification B.Sc Degree in one of the following disciplines: Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline.
• QP qualification is essential.
• 6 Years or more post educational experience 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 Laboratory/ plant start-up would be an advantage.
Primary Location:Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Quality (Generalist)
