QC Laboratory Supervisor (Microbiology)
Salary undisclosed
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- Design and Start-up Micro Lab on site.
- Supervise and coordinate resources to support routine and non-routine sample testing.
- Effectively recruit the right people to support the laboratories activities and ensure that human resources are optimally utilized.
- Ensure lab spending are appropriate and within planned budgets.
- Ensure all testing are carried out in a timely and efficient manner to meet release leadtime and site metrics and Release of laboratory test results.
- Review and approve any method transfer or method qualification reports or equipment qualifications.
- Provide oversight on lab equipment calibration and maintenance program.
- Investigate and/ or provide guidance to resolve any deviation observed during lab testing or any other lab operations, and ensure all CAPAs are implemented effectively.
- Develop and maintain environmental monitoring program and microbiological laboratory procedures.
- Lead validation of equipment and test methods for purified water.
- Lead test method transfer of microbiological method.
- Train laboratory team in operational tests and sampling methods.
- Participate and support audit preparation and audit responses, including the development and implementation of programs to provide timely follow up on correctives and commitments.
- Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Support CI initiatives and laboratory performance metrices.
- Provide technical support to laboratory personnel and provide guidance and training to all analysts to upgrade their technical competencies.
- Any other tasks as and when assigned by Supervisors.
- Bachelor of Science majoring in Microbiology or related scientific degree.
- Minimum 8 years of pharmaceutical experience in an analytical testing environment within Quality department and with good knowledge of aseptic processes manipulation together with experience within a GMP environment and knowledge of current EU/FDA/ICH/IMB guidelines.
- Minimum 3 years of supervisory experience in Biotechnology/Pharmaceutical Manufacturing area.
- Strong analytical mind with good problem solving and writing skills.
- Highly motivated and independent.
- Possess strong interpersonal and communication skills, with ability to work within cross-functional teams.
- Organized and result-oriented.
- Ability to work under tremendous pressures.
- Approachable with good leadership qualities.
- Design and Start-up Micro Lab on site.
- Supervise and coordinate resources to support routine and non-routine sample testing.
- Effectively recruit the right people to support the laboratories activities and ensure that human resources are optimally utilized.
- Ensure lab spending are appropriate and within planned budgets.
- Ensure all testing are carried out in a timely and efficient manner to meet release leadtime and site metrics and Release of laboratory test results.
- Review and approve any method transfer or method qualification reports or equipment qualifications.
- Provide oversight on lab equipment calibration and maintenance program.
- Investigate and/ or provide guidance to resolve any deviation observed during lab testing or any other lab operations, and ensure all CAPAs are implemented effectively.
- Develop and maintain environmental monitoring program and microbiological laboratory procedures.
- Lead validation of equipment and test methods for purified water.
- Lead test method transfer of microbiological method.
- Train laboratory team in operational tests and sampling methods.
- Participate and support audit preparation and audit responses, including the development and implementation of programs to provide timely follow up on correctives and commitments.
- Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Support CI initiatives and laboratory performance metrices.
- Provide technical support to laboratory personnel and provide guidance and training to all analysts to upgrade their technical competencies.
- Any other tasks as and when assigned by Supervisors.
- Bachelor of Science majoring in Microbiology or related scientific degree.
- Minimum 8 years of pharmaceutical experience in an analytical testing environment within Quality department and with good knowledge of aseptic processes manipulation together with experience within a GMP environment and knowledge of current EU/FDA/ICH/IMB guidelines.
- Minimum 3 years of supervisory experience in Biotechnology/Pharmaceutical Manufacturing area.
- Strong analytical mind with good problem solving and writing skills.
- Highly motivated and independent.
- Possess strong interpersonal and communication skills, with ability to work within cross-functional teams.
- Organized and result-oriented.
- Ability to work under tremendous pressures.
- Approachable with good leadership qualities.