Manager / Senior Manager – Microbiology (QC)Join to apply for the Manager / Senior Manager – Microbiology (QC) role at SAVA HEALTHCARE LIMITEDManager / Senior Manager – Microbiology (QC)14 hours ago Be among the first 25 applicantsJoin to apply for the Manager / Senior Manager – Microbiology (QC) role at SAVA HEALTHCARE LIMITEDGet AI-powered advice on this job and more exclusive features.Job Title: Manager / Senior Manager – Microbiology (QC)Location: Indore – Regulated Pharma Manufacturing PlantDepartment: Quality Control – MicrobiologyReporting To: Head – Quality ControlJob Type: Full-Time | Managerial LevelJob PurposeTo lead the Microbiology function in the QC department, ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements (USFDA, EU-GMP, MHRA, WHO, etc. ), and company quality standards by overseeing microbiological testing, environmental monitoring, sterility assurance, and microbiological risk assessments.Key ResponsibilitiesLeadership & Team ManagementLead and manage the microbiology team, ensuring training, development, and performance management.Provide technical guidance to resolve complex microbiological issues.Compliance & Regulatory ReadinessEnsure strict adherence to cGMP, GLP, and data integrity principles in all microbiological activities.Prepare and face regulatory inspections (USFDA, MHRA, EU, WHO-GMP) and ensure readiness through gap analysis and internal audits.Microbiological Testing OversightSupervise And Review All Microbiological Testing Activities IncludingEnvironmental Monitoring (EM)Water Testing (WFI, PW, HVAC, Compressed Air)Sterility Testing and Bacterial Endotoxin Testing (BET)Microbial Limit Tests (MLT)Bioburden & Identification of IsolatesDisinfectant Effectiveness Studies and Media Growth Promotion TestingDocumentation & Quality SystemsReview and approve microbiological protocols, SOPs, specifications, and reports.Investigate microbiological deviations, OOS/OOT results, and implement appropriate CAPAs.Ensure Timely Execution Of Qualifications For Microbiology Lab Equipment.Risk Assessment & Process ImprovementsLead microbial risk assessments for manufacturing processes and facility controls.Identify and implement continuous improvement initiatives within the microbiology lab.Coordination & CommunicationCollaborate with QA, Production, Engineering, and other departments for hygiene, contamination control, and new product support.Provide inputs during product and process changes, validations, and tech transfers.Key Skills & CompetenciesIn-depth knowledge of microbiological testing methods and aseptic techniques.Strong understanding of cleanroom classification, contamination control, and regulatory standards.Expertise in sterile and non-sterile product microbiology.Leadership and people management capabilities.Strong analytical, documentation, and communication skills.Educational QualificationsM.Sc. (Microbiology) / M.Pharm (Microbiology) or equivalent qualification in a life science discipline.Experience10–15 years of relevant experience in QC Microbiology in a regulated pharmaceutical environment, with at least 3–5 years in a leadership/managerial role.Preferred Certifications / TrainingsCertified training in cGMP, Data Integrity, Aseptic Practices, or Sterility Assurance preferred.Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionOtherIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at SAVA HEALTHCARE LIMITED by 2xSign in to set job alerts for "Senior Manager" roles.We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr