QC Microbiology Lab Manager
- Minimum: Bachelor's degree (preferably in Chemistry, Biochemistry or Microbiology. Desirable and preferred: Science, Engineering or Technical Degree related to Microbiology)
- Fluent both in English and Italian
- At least 10 years of relevant experience in Quality in pharmaceutical or related industry
- Demonstrated knowledge of cGMP and FDA requirements required
- Knowledge of computer systems
- Demonstrated compliant behaviors in a regulated manufacturing environment.
- Communication and management skills
- Ability to drive change culture in a complex environment
The incumbent leads assigned laboratory area and people related activities in a team responsible for Microbiology related microbiological testing and environmental monitoring activity. Responsible for managing all aspects of microbiology and environmental monitoring of both Siena and Rosia sites.
Description of the activities:
- Oversight of QC microbiological testing in assigned area including resource planning, associate training, workload planning and data authorization
- Review real-time laboratory procedures, executed test records and related documentation and data to ensure compliance with product license and GMP requirements
- Assure EHS&S procedures in place to avoid accident
- Actively maintain and promote a GMP compliant culture, ensuring the highest standards of data chain of custody, area housekeeping and safety are applied
- Lead laboratory phase I and phase II investigations for Out of Specification results according to GSK standards ensuring effective root cause analysis is performed, product quality implications are timely / accurately assessed and effective corrective and preventative actions are implemented
- Identify repeat deviations and ensure appropriate corrective actions are implemented
- Ensure quality performance is measured and communicated via quality forums and quality actions teams
- Support Annual Product Reviews
- Perform regular area inspections / support self-inspections and internal audits
- Provide guidance in clarifying any "grey" area in daily activities and ensure clear description of processes in procedures and supporting documentation and / or processes
- Adhere to the budget established by their next level and be responsible for technical problem solving, operational improvements, and efficiency improvements to optimize operating costs
- Maintain compliant analyst training status as per the standard operating procedures and coordinate with the Lab Managers the "on the job" training of analysts
- Ensure each analyst has a current job description and training matrix
You may apply for this position online by selecting the Apply now button.
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