Full job description
QA OfficerAbout the Role
Smart4 Sciences is partnering with a leading pharmaceutical company to recruit a QA Officer - Validation & Compliance. This is an excellent opportunity for someone with experience in pharmaceutical Quality Assurance who enjoys working across validation, compliance, technology transfer, and new product introduction activities.
Working within a GMP-regulated environment, you will play a key role in ensuring third-party manufacturers and laboratories remain compliant with regulatory requirements and registered dossiers while supporting the successful delivery of new product projects and ongoing quality initiatives.
Key Responsibilities
- Support new product development, technology transfers, and new product introductions from a Quality Assurance perspective.
- Coordinate and participate in project meetings with internal stakeholders and external manufacturing and testing partners.
- Review and approve analytical method validation, verification, and transfer protocols and reports.
- Review manufacturing and packaging process validation protocols and reports.
- Review Master Batch Manufacturing and Packaging Records, finished product specifications, methods of analysis, shelf-life specifications, and stability protocols.
- Evaluate technical documentation provided by Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).
- Assess Quality Management System documentation including Change Controls, Deviations, Out of Specification (OOS) investigations, CAPAs, and associated quality records.
- Maintain and update the Validation Master Plan to ensure ongoing compliance.
- Support investigations, market complaints, SOP updates, and continuous improvement activities.
- Contribute to site KPIs, product quality objectives, and Health, Safety & Environmental (HSE) standards.
- Build strong working relationships with internal departments including Regulatory Affairs, Supply Chain, Logistics, and Sales, as well as external CMOs and CTLs.
About You
We're looking for someone who has:
- Experience within Pharmaceutical Quality Assurance in a GMP-regulated environment.
- Knowledge of validation principles, including analytical method validation and process validation.
- Experience reviewing validation documentation, batch records, technical reports, and quality documentation.
- Good understanding of Change Control, CAPA, Deviations, OOS investigations, and Quality Management Systems.
- Familiarity with technology transfer and new product introduction activities would be advantageous.
- Excellent attention to detail with strong document review skills.
- Strong communication and stakeholder management skills.
- The ability to manage multiple priorities while meeting project deadlines.
- A degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related scientific discipline is desirable.
What's on Offer
- Opportunity to work on exciting new product and technology transfer projects.
- Exposure to cross-functional teams and external manufacturing partners.
- Career development within a growing pharmaceutical quality function.
- Supportive and collaborative working environment.
- Competitive salary and benefits package.
If you're passionate about pharmaceutical quality, validation, and compliance and want to play a key role in delivering high-quality products to market, we'd love to hear from you. Apply today!
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