Description
General QA Specialist Responsibilities:- Perform all activities in compliance with safety standards and SOPs
- Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Write, review and approve Standard Operating Procedures
- 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 of NCs and associated 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.
- Provides training and advice to staff in order for them to perform their desired functions. QA Technical Support and Disposition Function (may perform some or all of these duties)
- Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
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.
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and proven abilities in decision making
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
This is an urgent position offering competitive hourly rates. If you would like to hear more please contact me on or reply to this advert with a copy of your most recent 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.