The Company
Join a leading global biopharmaceutical organisation committed to quality, innovation, and patient impact. The site supports worldwide manufacturing and relies heavily on robust engineering and automation systems to maintain compliance and efficiency.
About the Role
As Quality Assurance Specialist, you will provide quality oversight for equipment, automation, and information systems validation. You work closely with engineering, maintenance, IS, and production teams to ensure processes meet GMP and regulatory expectations.
Key Responsibilities
• Review & approve validation documentation for equipment, automation & systems
• Provide QA support for engineering, maintenance & automation changes
• Participate in QRM activities (FMEA, risk assessments, computer compliance)
• Lead QA assessments for technical change controls
• Support quality investigations & compliance decisions
Qualifications & Requirements
• MSc in Engineering, Pharmaceutical Sciences, or similar
• 5–8 years of GMP experience
• Strong background in equipment/automation/IS validation
• Understanding of Annex 11, Part 11, computer compliance
• Solid analytical & communication skills
Other Information
A role with high visibility, strong cross-functional exposure, and impact on global-quality systems.
Looking forward to speaking with you!
56814
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.