Assistant Manager Microbiology
2 weeks ago
Job Summary:
To assist, organize, lead & control all activities in Microbiological lab. To ensure that activities and efforts in area of responsibilities result in timely availability of Finished Products and implementation of quality GMP and GLP, and team achievement.
Principal Duties:
- Ensure following activities of QC Microbiological Section:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â
- Timely availability of products                                        Â
- Introduction of new products                                         Â
- Quality, cGMP, GLP and Data Integrity requirements Â
- To lead & control of all activities fall in Microbiology laboratory.
- To perform all the Microbiological testing (as per approved method) required for Raw Materials, Finished Products, Water and Environmental monitoring, Growth Promotion Test, AMC, Preservative Efficacy test, Validation of Sterile & Non-Sterile Products, Equipment Qualification, and challenge test of autoclave and dry heat sterilizer.
- To prepare, update, and review SOPs and other relevant documents.      Â
- In case of any non-compliance with respect to testing, equipment, and other requirements, inform immediately to section manager and follow appropriate procedure to proceed further.
- To follow all SOPs used in Microbiological Section.
- To manage inventory of prepared media and culture as per frequency.
- To perform all Microbiological testing as per the approved methods) and protocols for facility / utilities / environment / equipmentâs and finished product validation.
- Train and certify staff if required.
- To avoid any delays in testing, keep follow ups with sampling group for in time sampling.
- To write procedure to cover all activities for effective use and control in the area and to ensure that all group members follow these SOPs.
- To maintain keep required standards of cleaning in Micro. Lab, washing area and autoclave room.
- To perform all validation activities related to utilities, finished products, raw materials, and environmental monitoring of manufacturing area.
- To ensure timely completion of Non-Volume Related Activities (Training Schedule, Reference Standards, annual Calibration/Maintenance Schedule of equipment, LIR / Â ER).
- To initiate change request, LIR / ER, OOS, QRA, SOPs on relevant quality systems and follow up for their approvals.
- Responsible to prepare and get approval of Quality Risk Management and Change Controls that comes under domain of Micro Lab.
- Any special project assigned by Sr. Manager QC or Head of Quality Assurance.
Knowledge & Experience:
- Knowledge of documentation, micro lab analysis, environmental monitoring, microbiological sampling of materials and finished products, technical problem resolution, and other activities taking place in Micro. Lab.
- 5-6 years of relevant experience in a similar position in a local and / or multinational Pharmaceutical Company.
Competencies required:
- Good computer skills
- Good Communication and interpersonal skills
- Good analytical skills
Minimum Qualifications:
- M.Sc. Microbiology
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