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Lead Quality Assurance Specialist
2 months ago
About Us
The Pharmaxo Group is a distinguished leader in the pharmaceutical and healthcare sector, dedicated to serving customers, patients, and healthcare professionals throughout the UK.
Our state-of-the-art manufacturing and office facility is situated in a modern science park, strategically located to facilitate our operations. The Pharmaxo Group encompasses:
Bath ASU which is responsible for the daily production of numerous aseptically compounded injectable pharmaceutical products, catering to hospitals and patients in need of critical care.
Pharmaxo Healthcare which is an expanding clinical homecare provider, enhancing patient convenience while optimizing efficiencies for the NHS.
Pharmaxo Scientific which focuses on pioneering innovations in biotechnology and information technology that propel 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 aligning with business requirements.
You will lead the daily operations of a segment of the QA Operations Team, supporting and executing tasks related to the Pharmaceutical Quality System, ensuring its robustness and effectiveness.
Your Duties & Responsibilities
- Manage QA release processes and worksheet verification during both day and late shifts, ensuring optimal workflow and efficiency.
- Provide ongoing support within the QA Team's rota system to fulfill service commitments, including Worksheet Checking, Batch Release, and documentation reviews.
- Generate and analyze regular reports against established KPIs for the QA team, sharing insights with QA Operations Team Leaders and the broader Quality Team.
- Ensure prompt investigation of complaints, deviations, and quality exceptions, approving initial inquiries and assigning corrective actions.
- Contribute to objectives outlined in the PQS system and support Bath ASU improvements or projects.
- Participate in quality audits and self-inspections to maintain high standards.
- Conduct final reviews of pre-manufacture batch documentation in accordance with GMP guidelines.
- Authorize the final release of all manufactured or repackaged products, adhering to licensing requirements and professional discretion.
- Serve as a primary contact within the QA team, providing information to other departments regarding production processes.
- Engage in continuous professional development, attending relevant training and update courses to maintain a high level of competency.
- Identify and report any non-conformances to appropriate personnel.
- Support the training and development of QA team members, conducting one-on-one meetings and performance reviews.
- Act as a deputy for the QA Operations Leader during absences.
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 increase based on training validations and performance metrics.
- Generous annual leave policy, increasing with tenure.
- Participation in an annual company bonus scheme, subject to eligibility.
- Pension scheme with employer contributions.
- Life assurance coverage.
- Access to employee support programs, including counseling and virtual healthcare services.
