Assistant Manager - Microbiology
- Cadila Pharmaceuticals
- 3 - 8 years
- Ankleshwar
- 24 hours ago
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Job Description
Job Title: Assistant Manager Microbiology (Reviewer)
Department: Quality Control Microbiology
Location: Ankleshwar, Gujarat
CTC: Up to 7.5 LPA
Qualification: M.Sc. (Microbiology or relevant discipline)
Experience: 5-8 Years
Industry Preference: API / Bulk Drug Manufacturing
Job Summary
We are looking for an experienced and detail-oriented professional for the role of Assistant Manager Microbiology (Reviewer) in the Quality Control department. The candidate will be responsible for microbiological analysis review, environmental monitoring, laboratory compliance, data integrity, instrument qualification, and regulatory documentation in an API manufacturing environment.
Key Responsibilities
Microbiology Laboratory Operations
- Allocate and monitor sampling and microbiological analysis activities for Unit-I, Unit-II, and Unit-III as per production and laboratory schedules.
- Review and approve microbiological analysis data for finished products, stability studies, APIs, water samples, and environmental monitoring.
- Ensure all analyses are performed as per approved specifications, SOPs, STPs, and analytical methods.
- Perform review of microbiological reports and Certificates of Analysis (COA).
Documentation & Compliance
- Prepare, review, and update SOPs, STPs, test procedures, validation protocols, and microbiology-related documents.
- Ensure compliance with cGMP, GLP, Data Integrity, and 21 CFR Part 11 requirements.
- Maintain laboratory records and documentation as per regulatory guidelines.
- Review trend data for water systems, environmental monitoring, and microbiological testing.
- Ensure timely completion and closure of OOS, OOT, deviations, change controls, NQI/QI, and market complaint investigations.
- Ensure analytical documents such as specifications, protocols, and reports are prepared as per SOP requirements.
Instrument & Laboratory Management
- Ensure calibration, qualification, maintenance, and troubleshooting of microbiology laboratory instruments.
- Maintain instrument history records, calibration schedules, and logbooks.
- Coordinate with service engineers for breakdown maintenance and preventive maintenance activities.
- Ensure backup and restoration verification of electronic analytical data on a monthly basis.
Media, Water & Environmental Monitoring
- Ensure timely availability of media, microbial cultures, chemicals, glassware, consumables, and laboratory accessories.
- Ensure proper media preparation and Growth Promotion Test (GPT) compliance.
- Ensure purified water testing and environmental monitoring activities are conducted as per schedule and SOP.
Safety & Training
- Maintain training records and analyst qualification records.
- Train laboratory personnel on safe handling of media, cultures, chemicals, reagents, gas cylinders, and laboratory instruments.
- Ensure safe disposal of microbial cultures and laboratory waste.
- Ensure proper segregation and storage of chemicals and test samples to avoid safety hazards.
Coordination & Team Support
- Coordinate with QA for cGMP compliance activities.
- Coordinate with Production for planning and clubbing of analysis.
- Inform and discuss quality issues, deviations, breakdowns, and incidents with department head for investigation and documentation.
- In absence of HOD, perform relevant departmental activities and responsibilities.
Required Qualifications & Experience
- M.Sc. in Microbiology or relevant discipline
- 1015 years of experience in QC Microbiology within API / Bulk Drug manufacturing
- Strong knowledge of microbiological laboratory operations and regulatory compliance
- Hands-on experience with LIMS and SAP systems preferred
- Experience in handling regulatory audits and data integrity requirements
Key Skills
QC Microbiology, Environmental Monitoring, Water Testing, API, Bulk Drugs, Microbial Analysis, GLP, GMP, Data Integrity, 21 CFR Part 11, OOS, OOT, Deviation Handling, Validation, Qualification, Stability Study, SOP Review, Regulatory Compliance, Caliber LIMS, SAP, Media Preparation, Growth Promotion Test, Laboratory Compliance, Instrument Qualification, Regulatory Audit
Preferred Candidate Profile
- Strong analytical and documentation skills
- Good understanding of regulatory expectations and microbiology practices
- Effective leadership and coordination abilities
- Strong communication and team management skills
Interested candidate can share there cv's at sh**********k@ca*********a.com
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality ConsultantEmployement Type: Full timeContact Details:
Company: Cadila PharmaceuticalsLocation(s): Ankleshwar
Keyskills: Microbiology API Microbial Analysis QC Microbiology Laboratory Compliance
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Cadila Pharmaceuticals
One of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad.
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