(High Salary) QA Specialist

2 days ago

Cork, Ireland Life Science Consultants (LSC) Full time

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 if you have any more questions about this role Skills: Quality Compliance Quality Systems Documentation

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