LSC have a great contract opportunity for a QA Specialist to join a leading pharmaceutical company based in Cork.
If you have 4+ years of experience in QA or similar function in the medical device, pharmaceutical or related industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
- Carries out tasks related to the management of batch records design and approval.
- Carries out administration of the SAP Quality Management Module.
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
- Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
- Carries out tasks related to the administration of site supplier approval process.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelors Degree in a scientific/technical discipline required
- A minimum of 3-5 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
Desirable:
- Experience in auditing of external suppliers, contractors and vendors.
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 Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
