Quality Assurance Senior Specialist (Hybrid role)
Reference: | RK34629 |
Location: |
Dublin
|
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
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.
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.
Key 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 Amgen’s safety standards, SOPs, and regulatory expectations.
- Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Education and 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 facility startup and Quality Oversight of Validation activities.
- 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.
- 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.