Position: Officer
Department: Microbiology
Location: Gozaria, Gujarat
Experience: 2-3 Year
About Celogen:
Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter/manufacturer based in India. The company provides it products and services in multiple countries globally including West Africa, East Africa, South Asia, South East Asia, the Middle East, and South America & Europe. Apart from promoting our branded products in the retail sector, we also participate in a number of global tenders in a number of countries. The team comprises of a group of first generation marketing expats and some of the best technocrats in the field. The company has four manufacturing bases in India, manufacturing a variety of products.
This job posting is in a hormone formulation manufacturing division of Celogen Pharma.
Job Summary:
The Microbiology Officer will be responsible for carrying out microbiological testing of raw materials, finished products, purified water, environmental monitoring samples, and utilities. The role involves maintaining laboratory compliance with cGMP, GLP, and Data Integrity requirements while ensuring accurate documentation and timely reporting of microbiological results.
Key Responsibilities:
- Perform microbiological analysis of raw materials, finished products, water samples, and environmental monitoring samples in accordance with approved specifications and test methods.
- Conduct environmental monitoring of classified manufacturing areas, including air, surface monitoring.
- Perform microbial limit tests as per approved procedures.
- Prepare and sterilize culture media, reagents, and microbiological solutions.
- Carry out microbial culture, identification, Gram staining, and routine microbiological laboratory activities.
- Operate and maintain microbiology laboratory equipment such as autoclaves, incubators, colony counters, laminar airflow units and biosafety cabinets.
- Perform growth promotion testing and media qualification as per regulatory requirements.
- Ensure routine monitoring and documentation of laboratory environmental conditions.
- Maintain laboratory records, worksheets, logbooks, and analytical reports in accordance with Good Documentation Practices (GDP) and Data Integrity principles.
- Assist in investigations related to Out of Specification (OOS), Out of Trend (OOT), deviations, contamination events, and environmental monitoring excursions.
- Participate in laboratory investigations, CAPA implementation, change control, and risk assessment activities.
- Support internal audits, regulatory inspections, and customer audits by providing required documentation and technical support.
- Ensure compliance with Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Environment, Health & Safety (EHS) guidelines.
- Maintain cleanliness, calibration status, and qualification records of laboratory equipment and instruments.
Qualifications:
- B.Sc. / M.Sc. in Microbiology
- B.Pharm / M.Pharm with relevant microbiology experience may also be considered.
- 2-3 years of experience in a pharmaceutical microbiology laboratory is preferred.
- Candidates with experience in regulated pharmaceutical manufacturing environments will have an added advantage.
Required Skills:
- Sound knowledge of pharmaceutical microbiology principles and laboratory techniques.
- Good understanding of cGMP, GLP, GDP, Data Integrity, and regulatory guidelines.
- Knowledge of environmental monitoring programs and microbiological testing procedures.
- Familiarity with laboratory instruments and microbiological equipment.
- Strong analytical, troubleshooting, and observation skills.
- Excellent documentation and reporting abilities.
- Basic computer proficiency (MS Office).
- Good verbal and written communication skills.
Pay: ₹180,000.00 - ₹300,000.00 per year
Education:
Experience:
- Microbiology within a tablet pharma manufacturing company: 2 years (Required)
Work Location: In person
