Overview
In this QA Officer role, you will serve as the QA representative for manufacturing activities and new products, ensuring GMP/GxP compliance and patient safety. You will review critical records, support deviations and investigations, and collaborate with cross-functional teams to resolve quality issues. You’ll contribute to risk assessments, change controls, and continuous improvement within a regulated pharma environment. This position offers hands-on ownership of quality activities across product lifecycles in a fast-paced setting.
Responsibilities
- Review and approve batch records, packaging records, lab data and process instructions
- Act as QA representative for new products, campaigns and change projects
- Manage and support deviations, non-conformances, investigations and OOS results
- Contribute to root cause analysis and CAPA implementation
- Participate in change controls, risk assessments, validation activities and product quality reviews
- Support internal audits, customer audits and regulatory inspection readiness
- Maintain QMS documentation (SOPs, protocols, reports, quality records)
- Support material and product disposition
- Collaborate with Production, QC, R&D and other departments to resolve quality issues
- Prepare quality trend reports and communicate findings to stakeholders
- Promote a strong culture of quality, compliance and continuous improvement
Key requirements
- Degree-qualified in Pharmacy, Chemistry, Biology or another relevant scientific discipline
- Quality Assurance experience in pharmaceutical or closely regulated environment
- Strong working knowledge of GMP/GxP requirements
- Knowledge of MHRA and FDA regulatory requirements would be advantageous
- Experience with QMS and controlled documentation
- Experience supporting batch record review, deviations, investigations, CAPA and change controls
- Strong analytical and problem-solving skills
- Excellent attention to detail and organizational ability
- Confident written and verbal communicator
- Ability to work independently and in cross-functional teams
- strong communication
- attention to detail
- problem-solving
- GMP/GxP knowledge
- QMS experience
- batch record review
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