Associate Manager Laboratory and Microbiology

vor 24 Stunden

Le Locle, Schweiz Integra LifeSciences Vollzeit

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Responsabilities
- Management of microbiologists and the laboratory technicians: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with companies G&O's.
- Ensures that adequate Microbiology and laboratory support is provided to production and to open projects / initiatives
- Ensures that Nonconformances related to sterilization, contaminations and OOS laboratory are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
- Ensures validation and management of Environmental monitoring (clean room, water, air, gas)
- Ensures validation /revalidation of all sterilization processes (ETO, Gamma and steam), including for new products
- Ensures management of bioburden and dose audit programs
- Review and approve laboratory documents and sterilization certificates
- Ensures technical support to the laboratory
- Review and assess supplier changes from a clean / sterilization aspect
- Ensures that Sterility and laboratory indicators are established and communicated
- Participates and supports internal and third-party audits / inspections
- Manages or participates to quality projects
- Provides support to complaint investigation if required
- Participates to procedure elaboration or update
- Ensures that CAPA under microbiology department responsibilities are managed and documented according to plans and in compliance with procedures
- Ensures support to process improvement projects
- Ensures that equipments in the laboratory are functional and correctly used in collaboration with maintenance and calibration
- Ensures that Biosafety program is maintain for Integra Le Locle site

**Qualifications**:

- A minimum of a Master or Degree PhD in Microbiology or a closely related field
- Founded knowledge and minimum 5 years experience of professional work experience as microbiologist.
- Experience in a Medical Device / pharmaceutical manufacturing.
- Fluent in French and English
- Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, EUMDR, 21 CFR part 820, ISO 10993-1, ISO 14644 series.
- Strong management skills
- Strong communication, organizational, negotiation and interpersonal skills
- Strong analytical problem-solving skills.
- The ability to collaborate with all levels of management across multiple sites and functions

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