LSC have a great contract opportunity for a QA Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 6+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Oversee and implement Quality Agreements relating to area of responsibility.
- Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines associated to Amgen Quality Systems.
- Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures.
- Oversight and management of Quality Risk Management (QRM) Processes and for the embedding of QRM principles within the quality framework.
- Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes and Documentation Management.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
- Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Sarina Abdulha on 021 4777 329 if you have any more questions about this opportunity!
