24 Sep
|
SAIN MEDICAMENTS
|
Uppal
24 Sep
SAIN MEDICAMENTS
Uppal
– Executive / Microbiology
Position: Executive – Microbiology
Department: Quality Control – Microbiology
Industry: Pharmaceutical Formulations
Experience: 2 Years
Location: Hyderabad
Job Summary
We are looking for a Microbiology Executive with around 2 years of experience in the pharmaceutical industry to support microbiological testing, environmental monitoring, sterility-related activities, documentation, and microbiology laboratory operations in compliance with GMP and established SOPs .
Key Roles & Responsibilities
1. Microbiological Testing
- Perform routine microbiological analysis of raw materials, finished products, water and other pharmaceutical samples as per approved specifications and SOPs.
- Perform microbial limit tests, total bacterial/fungal counts and specified microorganism testing as applicable.
- Perform and assist with sterility testing and related microbiological activities.
- Conduct growth promotion testing and media-related activities as per procedures.
2. Environmental Monitoring
- Perform environmental monitoring of classified areas through:
- Air sampling
- Settle plates
- Contact plates
- Surface monitoring
- Personnel monitoring
- Perform microbial monitoring of water systems and other controlled areas as per the approved monitoring schedule.
- Record, review and report environmental monitoring results.
3. Media Preparation & Laboratory Activities
- Prepare and sterilize microbiological media as per SOPs.
- Perform media growth promotion testing and maintain media preparation/usage records.
- Maintain microbial cultures and reference strains as required.
- Ensure proper cleaning, sanitization and maintenance of microbiology laboratory areas.
4. Documentation & GMP Compliance
- Prepare and maintain microbiology laboratory records, worksheets, logbooks and analytical reports.
- Ensure complete and accurate documentation in accordance with GDP and GMP requirements .
- Follow approved SOPs, specifications, test methods and safety procedures.
- Assist in maintaining microbiology-related documentation required for internal and regulatory audits .
5. Deviations / OOS / Investigations
- Immediately report abnormal results, contamination, excursions or laboratory incidents to the supervisor.
- Assist in investigations related to OOS, OOT, environmental monitoring excursions and microbial contamination .
- Support implementation of CAPA and other corrective/preventive actions as assigned.
6. Laboratory Equipment
- Operate and maintain microbiology laboratory equipment such as:
- Autoclave
- Incubators
- Colony counters
- Laminar Air Flow / Biosafety Cabinet, as applicable
- Microscope
- Water bath
- pH meter
- Maintain equipment usage, cleaning and calibration records.
- Ensure equipment is used within its qualified/calibrated status.
7. Safety & Compliance
- Follow laboratory safety, aseptic practices and contamination-control procedures.
- Handle microorganisms, cultures, chemicals and laboratory waste safely.
- Ensure proper segregation and disposal of microbiological waste.
- Maintain positive housekeeping and hygiene within the microbiology laboratory.
8. Coordination
- Coordinate with QA, Production, QC Chemistry and other relevant departments for sampling, testing and investigation activities.
- Support QA/QC teams during audits and inspections by providing required microbiology records and information.
Candidate Profile
- B.Sc./M.Sc. in Microbiology, Biotechnology or equivalent qualification.
- Around 2 years of relevant experience in pharmaceutical microbiology , preferably in a formulation/manufacturing environment.
- Hands-on experience in environmental monitoring, microbial testing, media preparation and microbiological analysis .
- Good understanding of GMP, GLP, GDP and microbiology laboratory practices .
- Knowledge of pharmaceutical water testing and microbial contamination control will be an advantage.
- Good documentation and communication skills.
- Ability to work effectively with QA/QC and cross-functional teams.
📌 Microbiologist (Uppal)
🏢 SAIN MEDICAMENTS
📍 Uppal