QA Specialist - Biopharma
QA Specialist required for an international biopharma client in Dublin South. Root cause analysis as well as non-conformance and deviation investigation experience essential.
Whilst this is a biopharmaceutical company, candidates from the pharmaceutical background are invited to apply. If you have between 4-9 years of quality specialist experience we'd like to hear from you.
This individual will be responsible to support wide QA function with an outreach to various departments.
- Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records.
- Input into Operating Procedures.
- Get involved in QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction.
- NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address the root cause and implementation plan dates are achievable.
- Be a Quality point of contact and decision maker during Technology Transfer and Process Validation activities whilst ensuring that all activities meet internal and regulatory expectations
- Provide input into Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review.
Job Compatibility Requirements
- Strong background in Root Cause Analysis / Non Conformance /Deviation investigations
- Experience with Regulatory inspections
- Working knowledge of aseptic operations, protein formulation, vial and syringe filling - is an advantage, but for the purpose of suitability is not essential.
This will range from €70-100k for an initial 12-month placement (with a view to permanency, or roll-over). Contracting through your own PLC is also an option.
Greater area of Blackrock, Killiney and Cabinteely.
Call 014744692 or email firstname.lastname@example.org - Click APPLY.
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