Quality Analyst Team Leader - Part Time
£38,000 - £42,000 (Pro Rata)
My client is a leading CDMO (Contract Development and Manufacturing Organisation) in the pharmaceutical industry employing almost 9,000 employees across the world. Offering manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material, APIs and pharmaceutical product development. Manufacturing several hundred different products to customers ranging from Big Pharma to smaller research and development companies.
Management and co-ordination of a Quality Operations Stability testing team. The Analytical Quality Leader will supervise a group of Analysts responsible for stability testing. Ensures that equipment and materials to perform testing are available and compliant. The Analytical Quality Leader is charged with responsibility of performing this function according to all Health & Safety standards, cGMP Regulatory requirements, Quality Standards, SOP's, budgetary controls and cycle time standards.
- Manages a team carrying out analytical testing of Stability samples in line with Regulatory and site commitments as well as the performance management of the team.
- Plan testing to assure all materials are released in accordance with agreed customer service deadlines and other production schedules so as not to delay normal production, distribution and marketing activities. Applies performance improvement tools, e.g. Lean/6 Sigma.
- Monitors results and trends, responds appropriately and assures that Quality issues are resolved in a timely manner with valid technical results so as not to delay production, distribution and marketing activities. Provides communication of Stability results to internal and external customers in a timely manner
- Co-ordinates various activities such as resolution of Quality issues, introduction of product material changes, new product transfers, validation projects and product launches with other departments.
- Performance manages the team through setting and reviewing priorities. Provides appropriate and timely feedback about performance and coaches team members to help them achieve their goals
- Supports the professional and career development of the team by identifying the skills and competencies that employees need for their current and prospective roles and provide opportunities to learn and practice new skills
Skills, Experience and Knowledge Requirements
- A science degree or equivalent relevant experience with at least 3 years working experience in a GMP environment.
- Leadership and People management skills (including managerial courage, informing, motivating, directing and confronting skills).
- Verbal and written communication skills at all levels both within the site organisation and externally.
- Resource management skills.
- High level of technical knowledge and expertise of quality control principles and systems in a cGMP environment.
- Thorough and practical knowledge of pharmaceutical products, processes and validation requirements and FDA/ Regulatory requirements.
- Laboratory experience and technical problem-solving skills.