Leading International Pharmaceutical Manufacturer seeks an experienced Sterility Assurance Manager.
About the role:
You will be responsible for providing technical expertise and supporting our aseptic compounding unit on all sterility assurance aspects. You will be a valuable and effective source of information and advice on sterility assurance and will positively contribute to the Quality Management Team and site, ensuring that the site maintains a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy and current industry trends. Reporting to the Head of Quality you will work with the existing Environmental Monitoring team, as well as sterility assurance colleagues in other manufacturing and global units.
Duties may include:
- Ensuring an effective sterility assurance and environmental monitoring program is deployed in the manufacturing facility, in compliance with current GMP. Provide strategic plan and expertise for the development and implementation of the site Contamination Control Strategy.
- Provides expert coaching and mentoring support locally on sterility assurance knowledge, practices and sterility awareness as part of the developing culture for the site.
- Responsible for the generation and evaluation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets. Responsible for follow-up of CAPA actions with the respective departments.
- Challenges technical and scientific aspects of facilities design and aseptic principals, with relevant stakeholders.
- Providing microbiological expertise and support for the sites for environmental monitoring investigations, corrective actions, process improvements and changes, where required reviewing and approving change control for sterility assurance compliance.
- Acting as a SME on sterility assurance in UK and as a primary Point-of-Contact for the relevant Regulatory Agencies during the on-site inspections and the relevant follow-up.
- Ensures the implementation of adequate training for aseptic gowning, aseptic qualification, practices and QA observations.
- Ensuring sterility Assurance is maintained throughout the supply chain. For incoming material by confirming adequate procedures are in place for visual observation of container closure integrity. For outgoing material confirming closure integrity is given for any packaging concepts of compounded products
- Assesses facility and quality systems' state of compliance with internal and corporate requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.
- Provides support and expertise to ensure that the compounding center applies all sterility assurance processes, including, Aseptic Practices, Environmental Monitoring, cleaning & disinfection, Aseptic Process Simulations and adequate product sterility verifications (e.g. regular sterility tests)
- Provide day to day support and improvements to the compounding center with oversight of the aseptic behaviors of operators with rapid feedback and CAPA development.
- Identifies improvement opportunities in monitoring, measurement and trending of results. Drives improvements based on current industry thinking and trends.
Skills and experience:
- Demonstrated leadership, interpersonal and influence skills in pharmaceutical industry (specifically specials manufacture) or medical devices, with the proven ability to teach and coach individuals from diverse backgrounds with varying communication and technical skills.
- A microbiology graduate with significant experience of aseptic techniques.
- Significant experience in implementing environmental control programs and OOL investigations and corrections
- Experience of microbiology in an aseptic facility.
- Experience interfacing with regulatory inspectors with a positive outcome.
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
- Preferably have Pharmacy Compounding experience.
- Experience in the interpretation and implementation of the MHRA Specials Guidance is preferable.
- Ability to communicate quality operations and compliance perspective effectively to senior management.
This role represents an excellent opportunity to join a global Pharmaceutical Manufacturer, with operations on multiple continents.
- Leading International Pharmaceutical Manufacturer seeks an experienced Sterility Assurance Manager.
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