LSC have a great contract opportunity for a Quality Specialist to join a leading biotech company based in Meath.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.
- Help maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.
- Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
- Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree or post-graduate qualification in Science, Pharmacy or equivalent with 4+ years' experience in QA.
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
- Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc
- Experience in performing internal audits and participating in external audits.
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!
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship currently. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett at 021 4777 329 if you have any more questions about this opportunity!
