Social network you want to login/join with:
Senior QA Specialist - Plant & Technical QA NPI/LCM, Dublin South
Location: Dublin South, Ireland
Job Category:
EU work permit required: Yes
Job Reference:
5084328_1735827415
Job Views:
22
Posted:
02.01.2025
Expiry Date:
16.02.2025
Job Description:
Global Biotechnology company, based in south Dublin, Ireland – looking for Snr. QA Specialist.
This would be a 24+ months contract opportunity with possible extension. The successful candidate will be responsible for providing overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Life-cycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
The Job:
1. Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities.
2. Validation Plans, Protocols, IQ, OQ, PQ and associated documents.
3. Executed validation documents and reports.
4. Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/Validation activities whilst ensuring that all activities meet company and regulatory expectations.
5. Provide Quality direction and input at Change Control Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
6. Quality review/approval of BOMs, MBRs and recipes.
7. Write, review and approve Standard Operating Procedures in accordance with company Policies.
Have You:
1. University degree. Science or engineering related discipline is preferred.
2. Relevant experience (6yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/technology transfer/product life-cycle changes.
3. Understanding of principles of Validation and New Product Introduction.
4. Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
5. Critical thinking skills.
6. Strong organisational, communication, coordination, and meeting facilitation skills.
7. Team players are prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
The successful candidate must have an eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organisations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to [emailprotected]
#J-18808-Ljbffr