Microbiology Manager
- Exemed
- 12 - 15 years
- Vadodara
- 12 hours ago
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Job Description
Laboratory Management
- Manage day-to-day operations of the QC Microbiology laboratory.
- Ensure timely testing and release of samples in accordance with production schedules.
- Allocate resources effectively to meet testing requirements.
- Monitor laboratory performance and implement continuous improvement initiatives.
- Ensure proper maintenance, calibration, qualification, and validation of microbiology laboratory equipment.
Microbiological Testing & Monitoring
- Oversee microbiological testing of:
- Purified Water (PW),
- Compressed gases
- Utility systems
- Environmental Monitoring (EM)
- Cleanroom monitoring
- Personnel monitoring
- Raw materials and process-related samples
- Review and approve microbiological test results and reports.
- Ensure compliance with USP, EP, IP, and other applicable pharmacopeial requirements.
Environmental Monitoring & Contamination Control
- Manage environmental monitoring programs for classified manufacturing areas.
- Establish and maintain contamination control strategies.
- Trend microbiological data and identify adverse trends.
- Conduct investigations related to microbial excursions and contamination incidents.
- Recommend corrective and preventive actions (CAPA).
Compliance & Regulatory Support
- Ensure laboratory compliance with cGMP, GLP, Data Integrity, and regulatory requirements.
- Support inspections by regulatory agencies such as:
- US Food and Drug Administration
- European Medicines Agency
- World Health Organization
- National regulatory authorities
- Participate in customer audits and quality assessments.
- Prepare and review SOPs, protocols, specifications, and validation documents.
Method Validation & Qualification
- Oversee microbiological method validation and verification.
- Manage growth promotion studies and media qualification.
- Review laboratory investigations including OOS, OOT, deviations, and change controls.
- Ensure implementation of risk-based quality management practices.
Team Management
- Lead, mentor, and develop microbiologists and laboratory personnel.
- Conduct training programs on GMP, aseptic practices, contamination control, and laboratory procedures.
- Perform performance evaluations and succession planning.
- Promote a culture of quality, compliance, and continuous improvement.
Data Review & Trending
- Review microbiological trend reports and KPI metrics.
- Ensure integrity, accuracy, and traceability of laboratory data.
- Support Annual Product Quality Reviews (APQR/PQR) through microbiological data analysis.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: MicrobiologistEmployement Type: Full timeContact Details:
Company: ExemedLocation(s): Vadodara+ View Contact
Keyskills: Microbiology
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Exemed
Exemed is a venture being initiated by a business group involved in manufacturing of Drug-intermediates & speciality chemicals, for more than three decades, having a reputation for high quality & reliability. Exemed offers end to end solutions starting from Intermediates, APIs to Finishe...
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