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Lead Quality Assurance Specialist
2 months ago
About Us
The Pharmaxo Group is a distinguished, industry-leading pharmaceutical and healthcare organization dedicated to serving customers, patients, and healthcare professionals throughout the UK.
Our modern manufacturing and office facility is situated in a prominent science park, providing a conducive environment for innovation and excellence. The Pharmaxo Group encompasses:
Bath ASU which specializes in the production of numerous aseptically compounded injectable pharmaceutical products daily, catering to hospitals and patients requiring critical care.
Pharmaxo Healthcare which is an expanding clinical homecare provider, enhancing patient convenience while optimizing efficiencies for the healthcare system.
Pharmaxo Scientific which pioneers advancements in biotechnology and information technology, propelling our business forward.
Your Role
In this position, you will oversee the provision of a safe and quality-driven aseptic manufacturing service, ensuring compliance with current Good Manufacturing Practices (cGMP) and meeting organizational needs.
You will manage daily operations within a segment of the QA Operations Team, supporting tasks related to the Pharmaceutical Quality System, ensuring its robustness and effectiveness.
Your Duties & Responsibilities
- Oversee QA release processes and worksheet evaluations during shifts, ensuring operational efficiency and appropriate task assignments.
- Provide ongoing support within the QA Team's rota system to fulfill service commitments, including worksheet checks and batch documentation reviews.
- Generate and analyze regular reports against established KPIs for the QA team, sharing insights with QA Operations Team Leaders or the broader Quality Team.
- Ensure prompt investigation of complaints, deviations, and quality exceptions, approving initial inquiries and recommending corrective actions.
- Support objectives outlined in the PQS system or Bath ASU improvement initiatives.
- Participate in quality audits and self-inspections.
- Conduct final reviews of pre-manufacture batch documentation in accordance with GMP guidelines.
- Approve the final release of all manufactured or repackaged products, adhering to licensing requirements and professional standards.
- Serve as a primary contact within the QA team, providing essential information to other departments involved in production processes.
- Engage in continuous professional development, attending relevant training and courses to maintain a high level of competency.
- Identify and report any non-conformances to the appropriate personnel.
- Assist in the training and development of QA team members.
- Conduct one-on-one meetings and performance reviews for QA Officers.
- Act as a deputy for the QA Operations Leader during their absence.
The Skills & Attributes You Will Bring
- Comprehensive knowledge of GMP standards.
- Strong problem-solving capabilities.
- Excellent written and verbal communication skills.
- Effective interpersonal skills.
- Ability to prioritize and manage workload efficiently.
- Exceptional attention to detail.
Benefits
- Competitive starting salary with potential for increases based on training and performance metrics.
- Generous annual leave policy, increasing with tenure.
- Eligibility for an annual company bonus scheme.
- Pension plan with employer contributions.
- Life assurance coverage.
- Access to an Employee Assistance Programme and additional health services.
