Qa Specialist (Senior) - C&Q

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 (SOPs) 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 EU passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) or send your profile to

#J-18808-Ljbffr