Pharmaceutical QA Expert
4 days ago
About the Position:
This is an excellent position for anyone looking to join a leading multinational who is one of the best at what they do. We are currently recruiting for an exciting opportunity with a pharmaceutical organization based in Tipperary.
Key Responsibilities:
- Support the Engineering Department in a GMP and Sterile Environment.
- Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety, and reliable supply to our customers.
- Direct and lead deviations, out-of-tolerance conditions, and unexpected results, conducting failure analysis, root cause determination, and implementing corrective actions.
- Prepare and analyze engineering metrics reports to trend for improved operational efficiencies.
- Format, write, deliver, and review necessary documentation in line with the standard approval process and facilitate others to do so.
- Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks.
- Comply with Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture in Carlow.
Requirements:
- Third-level degree qualified in a Science/Engineering or related discipline.
- 3-5 years prior related work experience ideally in a manufacturing, preferably GMP setting.
- GMP Audit experience in the pharmaceutical industry.
- Experience with documentation such as SOPs, SWIs, training documents, JSAs, PMs, and change controls.
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