Senior Quality Assurance Specialist - Technical
PE Global are recruiting for a Senior Quality Assurance Specialist – Technical QA for our biopharmaceutical client based in Dun Laoghaire, Dublin.
This is an initial 24 months with potential extension. Hybrid working, 3 days a week onsite.
This is a unique opportunity to play a key role in a high-impact project, providing Quality Oversight across Facility, Equipment, Utility, and Process Design, Installation, and Qualification. This role requires a strong focus on QA leadership in the design, installation, and qualification of facility, equipment, utility, and process systems, with particular emphasis on Validation Oversight.
Job Responsibilities
* Provide QA leadership during facility design, and layout
* Provide overall quality direction for processes and procedures associated with project
* Lead QA review and approval of URS, DS, QRAEs, and IQ/OQ/PQ protocols and reports.
* Act as the Quality point of contact and decision-maker during validation execution activities, ensuring all activities comply with regulatory and company standards.
* Ensure Computerised System Validation (CSV) meets regulatory and data integrity standards.
* Ensure validation documentation is robust, traceable, and inspection-ready.
* Drive risk assessments and mitigation strategies for new equipment and processes.
* Provide QA oversight for Change Controls, CAPAs, and Deviation Investigations.
* Ensure all activities align with company safety standards, SOPs, and regulatory expectations.
* Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Educations & Experience
* University degree in a Science or Engineering-related discipline.
* Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
* Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle 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.
* Excellent organizational, communication, and collaboration skills.
* Ability to work independently with minimal supervision and operate effectively across functional boundaries.
* Critical thinking and problem-solving abilities.
Additional Skills
* Familiarity with Quality by Design (QbD).
* Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
* Team-oriented mindset with the ability to thrive in a collaborative decision-making culture.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to chloe.slingsby@peglobal.net
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Manufacturing and Quality Assurance
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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