Open role
QA Officer
- Aggregated by CV-Library
- Widnes, Cheshire
- Permanent
- Full Time
Job Description
QA Officer
About 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
About 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