To perform microbiological testing, preparation of media, sterilization of glassware, and analysis of finished products and water samples. Ensure compliance with regulatory guidelines and support HVAC validation and calibration activities (DQ/IQ/OQ/PQ).
Key Responsibilities:1. Microbiological Testing
Conduct microbiological testing of
finished products
and
water samples
as per SOPs and regulatory standards.
Perform environmental monitoring including HVAC system checks.
2. Media Preparation & Sterilization
Prepare microbiological media and reagents accurately according to prescribed methods.
Sterilize glassware, media, and equipment using autoclaves and other sterilization methods ensuring no contamination.
3. Validation & Calibration
Support HVAC system validation activities including
Design Qualification (DQ)
,
Installation Qualification (IQ)
,
Operational Qualification (OQ)
, and
Performance Qualification (PQ)
.
Assist in preparation and review of
User Requirement Specifications (URS)
.
Participate in calibration of laboratory instruments and equipment as per schedule.
4. Documentation & Compliance
Maintain accurate records of microbiological testing, sterilization logs, calibration certificates, and validation reports.
Ensure adherence to
GMP, GLP
, and regulatory requirements.
Assist during regulatory audits and inspections.
5. Regulatory and Quality Support
Support quality assurance activities related to microbiological aspects.
Handle deviations, CAPA, and change controls related to microbiology and sterilization processes.
Required Skills:
Good understanding of microbiological techniques and sterility testing.
Experience with media preparation and sterilization procedures.
Knowledge of HVAC systems and their validation.
Familiarity with DQ, IQ, OQ, PQ protocols.
Strong documentation and data integrity awareness.
Ability to work under GMP/GLP guidelines.
Good communication and teamwork skills.
Job Types: Full-time, Permanent
Pay: ?300,000.00 - ?600,000.00 per year
Benefits:
Food provided
Health insurance
Paid sick time
* Provident Fund
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