Quality Specialist (Operations)-1402716W
Description
Position Title: Quality Specialist (Product)
Department: Quality
Report to: QA Manager
Location: Limerick
Travel: 10%
Company Summary:
J&J Ireland, New Facility, Limerick.
Position Summary:
QA responsible to provide support for Operational activities.
Main duties and responsibilities:
• Resolve and assist in the closure of all operational related 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.
• QA input (review and approval) for Process Development activities eg. Characterization Studies, Optimization Studies, Test Method Validation etc.
• QA input for all production related activies.
• QA review of Batch Record documentation.
• Support preparation, review, approval and execution (where applicable) of site related documentation (Tranfer Strategies/Plans, Procedures, Batch Record updates, Risk Assessments, SOP’s etc.)
• Ensure output of studies are incorporated to relevant commercial documentation.
• Recommend Process Improvements.
• Implement, deploy and revise as applicable procedures.
• Provide support and advice during cross functional investigations / projects and as required.
• Provide guidance to project teams on Validation strategy and approach.
• Review / Approval of Validation Protocols ( e.g. Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Review / Approval of Validation Reports ( e.g. Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Develop/Review/Approve Validation Master Plans
• Conduct Staff Training (Risk Management, Verification / Validation).
• Generate SOP’s/other documentation as applicable.
• Define and Implement the Batch Release Process.
• 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 in Ethicon Biosurgery
Qualifications
Key Skills and Competencies required:
• Proficiency in applicable GMP/QSR regulations.
• Ability to Troubleshoot and carry out Root cause analysis.
• 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
• QP qualification is desirable.
• 4-6 Years 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 process and utility plant start-up would be an advantage
• Statistical Analysis competency required
• Good level of computer literacy required
Primary Location:Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Quality Assurance
Description
Position Title: Quality Specialist (Product)
Department: Quality
Report to: QA Manager
Location: Limerick
Travel: 10%
Company Summary:
J&J Ireland, New Facility, Limerick.
Position Summary:
QA responsible to provide support for Operational activities.
Main duties and responsibilities:
• Resolve and assist in the closure of all operational related 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.
• QA input (review and approval) for Process Development activities eg. Characterization Studies, Optimization Studies, Test Method Validation etc.
• QA input for all production related activies.
• QA review of Batch Record documentation.
• Support preparation, review, approval and execution (where applicable) of site related documentation (Tranfer Strategies/Plans, Procedures, Batch Record updates, Risk Assessments, SOP’s etc.)
• Ensure output of studies are incorporated to relevant commercial documentation.
• Recommend Process Improvements.
• Implement, deploy and revise as applicable procedures.
• Provide support and advice during cross functional investigations / projects and as required.
• Provide guidance to project teams on Validation strategy and approach.
• Review / Approval of Validation Protocols ( e.g. Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Review / Approval of Validation Reports ( e.g. Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
• Develop/Review/Approve Validation Master Plans
• Conduct Staff Training (Risk Management, Verification / Validation).
• Generate SOP’s/other documentation as applicable.
• Define and Implement the Batch Release Process.
• 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 in Ethicon Biosurgery
Qualifications
Key Skills and Competencies required:
• Proficiency in applicable GMP/QSR regulations.
• Ability to Troubleshoot and carry out Root cause analysis.
• 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
• QP qualification is desirable.
• 4-6 Years 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 process and utility plant start-up would be an advantage
• Statistical Analysis competency required
• Good level of computer literacy required
Primary Location:Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Quality Assurance