Global Biotechnology company, based in Dublin Ireland - looking for
QA Senior Specialist
.
This position requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C&Q / Validation requirements.
The Job:
* Quality Oversight of new equipment qualification.
* Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation
* Act as the Quality point of contact and decision-maker C&Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
* Quality review and approval of validation documentation.
* Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
* Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
* Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction.
* Provide input and quality oversight for change control development and implementation.
* Write, review, and approve Standard Operating Procedures (SOP's) in alignment with company policies.
Have You:
* University degree in a Science or Engineering-related discipline.
* Minimum of 8 years of relevant experience in the pharmaceutical or biotechnology industry.
* Proven expertise in new equipment introduction, technical transfer, PPQ execution, and life-cycle management.
* Strong understanding of validation principles and regulatory requirements for C&Q / Validation (FDA, EMA guidelines).
* Experience with change control, non-conformance resolution, and CAPA implementation.
* Familiarity with Quality by Design (QbD).
* Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at or send your profile to -