Sterile Operations Sr Quality Manager
4 settimane fa
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
**Scope of role/responsibility**
- The Sterile Operations Sr Quality Manager is in charge with owning the oversight, de-risking and improvement of the aseptic processes on site. They will be the leader or main involved parties in the process improvement for micro lab technologies.
- Guarantee that the production process of the injectable sterile pharmaceuticals is crafted and implemented in order to ensure the appropriate sterility assurance level, with outstanding practices, in conformity to the current procedure and the cGMP normative.
- The Sterile Operations Sr Quality Manager guarantees assistance during the regulatory inspections regarding sterility assurance.
- They are the site representative in the Global Sterility Assurance Group, representing the site and acting as a SPOC to demonstrate global experience.
- Provide guidance and direction in the implementation of the site contamination control strategy
- They drive the Sterility Academy in order to improve the aseptic technics applied by Sterile Operators and improve their knowledge concerning microbiological matters.
**Specific responsibilities/main activities**:
**Sterility Assurance**
- Build and supervise the Contamination Control Strategy for the site in compliance to Regulations, supporting continuous evolution in the requirements from Regulators and Clients.
- Lead all aspects of the site Media Fill program to assure a critical approach to introduction of new products, areas, equipment, changes and accurate planning of MF activities.
- Provide vision on the design of and provide oversight to the effectiveness of the EM system, identify any weaknesses and initiate any required improvements
- Support the surveillance of the maintenance activities to be carried out within the sterile department, in respect to the current procedures, giving the vital directions so that such interventions are performed to reduce the environmental contamination and the product risk to a minimum.
- Collaborate within the investigation team for the management of the quality events with an impact on sterility, supporting the evaluations on deviations and complaints with microbiology impact.
- Review & approve any Major/Critical deviation and any corrective and preventive actions with Sterile Assurance impact
- Proactively analyze the critical working phases of the process, the system areas at potential impact and assess the ordinary and extraordinary maintenance intervention type to be carried out.
- Actively participate in the identification, development and/or review and revision of SOPs and assessments that have impact on the sterility assurance.
- Actively participate in the evaluation of changes which may have impact on the quality of the sterile products.
- Assure that adequate trend analyses are carried out from the environmental monitoring data for viable and non-viable particles.
- Assure the surveillance plan of the aseptic technique activities, the identification and the implementation of the eventual corrective actions in order to fill the gap identified (overlooking and Fit & Finish).
- Support the Validation team in the qualification and validation approach definition of new instruments\processes or new production areas (HVAC, sterilization\de-pyrogenation, classification rooms, media fill) in terms of sterility assurance.
- Support the Engineering team in the definition of the projects of new utilities, new production areas or installations of new equipment, in terms of sterility assurance especially in the design phase.
- Support the auditing activities at other sterile sites and suppliers providing microbiological service or sterile materials
**Relations**:
All functions, Global Quality functions, Customers, inspectors & Auditors
**Requirements**:
Degree in a Scientific Area (Pharma or Biotech Field, Microbiology Field can be preferred)
**Technical skills**
Basic and Specialist Analytical techniques
Background on sterility assurance, on process and cleaning validation concepts and contamination control strategy relations, microbiological concepts
- Statistical knowledgeSound updated knowledge of aseptic manufacturing within the (bio) pharmaceutical industry, knowledge of cGMP require
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