LSC has an exciting opportunity for a QA Specialist to join a pharmaceutical company in Cork. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture.
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- The API EM Quality Assurance Specialist provides support to all quality activities at Contract Manufacturing organizations (CMs).
- The QA Specialist position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
- Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
- Escalate quality issues at CMs to QA management.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs)
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.
- Thorough technical understanding of quality systems and regulatory requirements.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Cian Marnane at LSC on 021 4777329 if you have any more questions about this role!
