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:
Management Review Process
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.
Requirements:
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.
Package:
Permanent Full time position
Competitive salary
Benefits - Pension, healthcare etc
Performance bonus schemes
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
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JJob Description
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:
Management Review Process
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.
Requirements:
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.
Package:
Permanent Full time position
Competitive salary
Benefits - Pension, healthcare etc
Performance bonus schemes
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Amgen Jobs - Dublin
Genzyme Jobs - Waterford
J
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
