Senior Officer

Cadila Pharmaceuticals Limited; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Cadila Pharmaceuticals Limited seeks a qualified Microbiology Reviewer/Senior Officer to support microbiological testing and documentation review in an API manufacturing facility.

The role requires hands-on API microbiology testing, environmental monitoring, and data review with strong GDP/GLP understanding. This position emphasizes accurate records, compliance with GMP and effective collaboration across QC, QA, and production teams.

Qualifications

• Bachelor-like or higher in Microbiology with practical laboratory experience.
• Experience in pharmaceutical microbiology and API manufacturing preferred.
• Hands-on experience in environmental monitoring and data review.
• Knowledge of GDP/GLP and GMP requirements is essential.
• Strong written and verbal communication and documentation skills.

Responsibilities

• Perform and review microbiological testing of APIs, materials, and water.
• Review microbial data, worksheets, reports and lab records for accuracy.
• Ensure compliance with SOPs and pharmacopoeial requirements.
• Conduct environmental monitoring and review results against thresholds.
• Support investigations, CAPA, deviations and internal audits.

Skills

Analytical skills

Documentation review

Communication skills

Quality systems knowledge

Education

M.Sc. in Microbiology

Job description

We are looking for a qualified and experienced Microbiology Reviewer / Senior Officer to support microbiological testing and documentation review in an API manufacturing facility. The candidate should have hands‑on experience in API microbiology testing, environmental monitoring, and review of microbiological data and records, with a strong understanding of Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).

Key Responsibilities

1. API Microbiology Testing and Review

   • Perform and review microbiological testing of APIs, raw materials, intermediates, process samples, and water samples, as applicable.
   • Review microbiological analytical data, raw data, worksheets, test reports, and laboratory records for accuracy, completeness, and compliance.
   • Review microbial limit tests, total microbial count, and specified microorganism testing, as applicable to approved specifications and methods.
   • Verify test results against approved specifications, standard operating procedures (SOPs), and applicable pharmacopoeial requirements.
   • Ensure timely completion of microbiological testing, documentation, and reporting.
   • Identify discrepancies in analytical records and coordinate their resolution with laboratory personnel.

2. Environmental Monitoring

   • Perform and review environmental monitoring activities in applicable manufacturing and laboratory areas.
   • Conduct or review viable and non-viable monitoring, as applicable to the facility and established procedures.
   • Perform or review settle plate, active air sampling, and surface monitoring activities.
   • Monitor environmental monitoring results against established alert and action limits.
   • Identify environmental excursions and support investigations, root cause analysis, and CAPA implementation.
   • Ensure proper documentation, trending, and reporting of environmental monitoring results.

3. Documentation Review and Compliance

   • Review microbiology laboratory records, analytical worksheets, logbooks, and test reports.
   • Ensure compliance with GDP, GLP, applicable GMP requirements, and internal quality procedures.
   • Verify that laboratory documentation is accurate, complete, traceable, and maintained according to approved procedures.
   • Ensure adherence to data integrity principles and good documentation practices.
   • Maintain and review records related to media preparation, sterilization, culture handling, and laboratory equipment, as applicable.

4. Quality Management and Investigations

   • Support investigations related to microbiological failures, environmental monitoring excursions, and out-of-specification (OOS) results.
   • Assist in identifying root causes and implementing corrective and preventive actions (CAPA).
   • Participate in deviation investigations and change control activities, as required.
   • Support internal audits, customer audits, and regulatory inspections.
   • Ensure compliance with approved SOPs, microbiological testing procedures, and laboratory safety requirements.

5. Laboratory Operations

   • Ensure proper handling, preparation, labeling, storage, and disposal of microbiological media and cultures.
   • Verify the suitability and performance of culture media, where applicable.
   • Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.
   • Maintain laboratory cleanliness, biosafety, and contamination control practices.
   • Coordinate with QC, QA, Production, and other relevant departments to resolve microbiological quality issues.

Mandatory Requirements

• Qualification: M.Sc. in Microbiology.
• Experience: 4–6 years in pharmaceutical microbiology, preferably in API manufacturing.
• Hands‑on experience in API microbiological testing and review.
• Practical experience in environmental monitoring and review of monitoring data.
• Mandatory knowledge of Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).
• Good understanding of applicable GMP requirements, microbiological methods, and laboratory documentation.
• Strong analytical, review, documentation, and communication skills.

Preferred Skills

• Knowledge of pharmacopoeial microbiological testing methods, including relevant IP, USP, or Ph. Eur. requirements.
• Experience with microbial limit testing, water microbiology, and environmental monitoring trend analysis.
• Familiarity with OOS investigations, deviations, CAPA, and data integrity requirements.