Description
Responsibilities:- Perform all activities in compliance with safety standards and SOPs
- Provide Quality direction and input at Change Control and Review Boards and assume oversight of change control and CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Write, review and approve Standard Operating Procedures in accordance with policies.
- Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
- Review and approval CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
- Participates in customer complaint investigations.
Basic Qualifications:
- University degree - Engineering or Science related discipline preferred.
- Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications:
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
- Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
If you would like to apply for this position please call Sarah Irvine on or respond with an updated version of your CV. We also offer shopping vouchers for any successful referrals so if you know of anyone who may be suitable please feel free to get in touch.