Posted: 24 March
Offer description
QA Compliance Specialist
We are currently recruiting for an exciting opportunity with a leading multinational Pharmaceutical organization based in Tipperary.
This is an excellent position for anyone looking to join a world-class company that consistently delivers high-quality results.
About the Role:
This role will be responsible for supporting the Engineering Department in a GMP and Sterile Environment, ensuring objectives are effectively achieved while maintaining compliance, safety, and reliable supply to our customers.
Duties and Responsibilities:
* 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.
* Document types include SOPs, SWIs, training documents, JSAs, PM's, and change controls.
* Lead investigation analysis, identify true root cause, identify gaps, and implement actions to close gaps.
Collaboration and Accountability:
Collaborate with Engineering colleagues and other departments, particularly IPT, Quality, EHS, Technical Engineering, to complete tasks.
Accountable for complying with Global Policies, Procedures, and Guidelines, regulatory requirements, and executing current Good Manufacturing Practices (cGMP) in day-to-day activities and applicable job functions.
Supporting a Safe and Compliant Culture:
Work collaboratively to drive a safe and compliant culture in Carlow.
Additional Responsibilities:
May be required to perform other duties as assigned. Support Audit Readiness activities.
Requirements:
* Third Level Degree qualified in a Science/Engineering or related discipline.
* 3-5 years prior related work experience, ideally in a manufacturing environment, preferably GMP setting.
* GMP Audit experience in the pharmaceutical industry.
* Experience with documentation such as SOPs, SWIs, training documents, JSAs, PM's, and change controls.
