We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
* 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 companies safety standards, SOPs, and regulatory expectations.
* Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Educational and Experience
* University degree in a Science or Engineering-related discipline.
* Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
* Familiarity with Quality by Design (QbD).
* Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
We are an equal opportunities employer and welcome applications from all qualified candidates.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance and Manufacturing
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