JOB RESPONSIBILITY
1. Oversee QC Micro/EM teams.
2. In charge of QC EM and Micro team which covers the critical utilities, environmental monitoring testing program and microbiological testing for water, raw material, in-process and release samples.
3. Manage environmental monitoring and site contamination control programs, including EM risk assessment, testing, trending, interpretation of EM data, and oversight of the EM excursion business process. Lead investigations and/or change control strategies for processes that impact environmental control. Work closely with stakeholders in manufacturing, engineering, and validation to drive alignment to site contamination control goals and standards.
4. Responsible for establishing the microbiology testing/qualification function. Serve as a member of the QC organization and SME on microbiological assays and new technology. Provides key input and recommendation of data review or investigation process. Serves as lead for client discussions regarding project quality or investigations.
5. Supervise, plan, and review operations for assigned staff, including responsibility for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work.
6. Conduct and direct assays and lab procedures according to and in compliance with GDP cGMP, CFR and/or PIC/S guidelines and company SOPs. Conduct critical review of results and reports data appropriately.
7. Author, review, and approve SOPs, validation protocols, investigations, specifications, and related documents. Closely work with staff members to initiate deviations, CAPA, OOS, and OOL investigations.
8. Provides middle level operational, technical, and administrative leadership to the Microbiology/EM team through supervision and planning. Supervise, plan, and review operations for assigned staff members, including responsibilities for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work.
9. Work with supervisor to plan and budget for team manpower, supplies and equipment resources.
10. Oversee the implementation and continual improvement of the QC processes. Advise staff on areas of improvement, QC focus areas and efficiency in the quality control process.
11. Closely work with internal and external stakeholders to ensure that the appropriate information is effectively communicated and documented.
12. Any other tasks or projects deemed necessary by the superior/QC head to support the QC department.
Requirement
1. Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
2. 6+ years of relevant experience or equivalent for Bachelors’
3. 4+ years for Master’s in the Quality Control or related field or equivalent experience.
4. 2 years of Management experience required.
Other requirements (e.g.: working time, special skills)
1. Knowledge of microbial contamination control, microbiological methods and demonstrated capability in using that knowledge to provide Quality leadership to all aspect of microbiology.
2. Subject matter expertise (SME) and hands-on proficiency with all aspects of pharmaceutical microbial control.
3. Experience and understanding of environmental control regulations and guidelines with in-depth understanding of cGMP.
4. Scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures related to analytical and microbiological methods.
7. Experience in validating and executing microbiological testing methods, identification methods, and evaluating new technology and methods.
8. Experience with application of root cause analysis tools for investigation execution.
9. Experience with Quality Systems (e.g. Document/Quality/Learning management system, Change Control, Deviations, and CAPA programs).
10. Able to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
11. Self-motivated and organized.
12. Good communication skills (both verbal and written) and interpersonal skills are required.