QA Officer
Job Description
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.
\nWorking 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\n- \n
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Support new product development, technology transfers, and new product introductions from a Quality Assurance perspective.
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Coordinate and participate in project meetings with internal stakeholders and external manufacturing and testing partners.
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Review and approve analytical method validation, verification, and transfer protocols and reports.
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Review manufacturing and packaging process validation protocols and reports.
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Review Master Batch Manufacturing and Packaging Records, finished product specifications, methods of analysis, shelf-life specifications, and stability protocols.
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Evaluate technical documentation provided by Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).
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Assess Quality Management System documentation including Change Controls, Deviations, Out of Specification (OOS) investigations, CAPAs, and associated quality records.
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Maintain and update the Validation Master Plan to ensure ongoing compliance.
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Support investigations, market complaints, SOP updates, and continuous improvement activities.
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Contribute to site KPIs, product quality objectives, and Health, Safety & Environmental (HSE) standards.
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Build strong working relationships with internal departments including Regulatory Affairs, Supply Chain, Logistics, and Sales, as well as external CMOs and CTLs.
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We're looking for someone who has:
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Experience within Pharmaceutical Quality Assurance in a GMP-regulated environment.
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Knowledge of validation principles, including analytical method validation and process validation.
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Experience reviewing validation documentation, batch records, technical reports, and quality documentation.
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Good understanding of Change Control, CAPA, Deviations, OOS investigations, and Quality Management Systems.
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Familiarity with technology transfer and new product introduction activities would be advantageous.
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Excellent attention to detail with strong document review skills.
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Strong communication and stakeholder management skills.
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The ability to manage multiple priorities while meeting project deadlines.
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A degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related scientific discipline is desirable.
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Opportunity to work on exciting new product and technology transfer projects.
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Exposure to cross-functional teams and external manufacturing partners.
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Career development within a growing pharmaceutical quality function.
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Supportive and collaborative working environment.
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Competitive salary and benefits package.
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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!
