Description
World leading Biopharmaceutical client currently have a long term contract requirement for an experienced Quality Assurance Specialist with good experience of working within a filling line (either syringe fill or vial fill).As QA Specialist you will be a core member of the project team that is designing, building, commissioning a new state of the art pharmarceutical packaging facility, achieving regulatory approval for ongoing commercial operations.
You will serve as the Quality reviewer and approver on project milestones & documentation such as risk assessments, commissioning, qualification & validation activities.
Reporting to the Director of Quality key responsibilities will include:
Key Responsibilities:
- Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
- Review and edit project documentation ensuring that Quality requirements are met
- Provide QA approval on finalized project documentation
- Contribute to equipment and process risk assessments
- Provide QA oversight for equipment qualification and commissioning activities including but not limited to factory acceptance testing and site acceptance testing
- Evaluate validation protocol content and execution
- Is a champion for safe working practices and safety initiatives within their area
Qualifications
-University degree. Engineering or Science related discipline preferred
- Significant experience (10yrs +) working in the pharmaceutical or biotechnology industry
Preferred Qualifications
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and influencing decisions
- Experience working in aseptic operations, protein formulation, syringe filling
- Experience working with isolator and e-beam technology
- Experience with ASTM 2500 approach to equipment commissioning and qualification
- Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
- Knowledge of applicable Regulatory requirements
- Experience with Regulatory inspections
- Operational Excellence experience
This is a long term opportunity which could go on for up to three years. Good Day rate for the right candidate.