Job Title: QC Expert in Microbiology
Experience Level: 6-9 years
Location: Hyderabad
Job Summary:
We are seeking an experienced Microbiologist with 7–9 years of experience in the pharmaceutical API industry. The candidate will be responsible for microbiological testing, environmental monitoring, and ensuring compliance with regulatory standards such as GMP.
Key Responsibilities:
- Perform microbiological analysis of raw materials, in-process samples, finished products, and water systems
- Conduct environmental monitoring in manufacturing and controlled areas
- Handle microbial limit tests, sterility testing (if applicable), and endotoxin testing
- Maintain and calibrate microbiology laboratory instruments
- Ensure compliance with GMP, GLP, and regulatory requirements (e.g., USFDA, WHO, EMA)
- Prepare, review, and maintain SOPs, protocols, and validation documents
- Investigate deviations, OOS (Out of Specification), and implement CAPA
- Participate in internal and external audits and regulatory inspections
- Support method validation and method transfer activities
- Train junior staff and ensure adherence to lab safety standards
Requirements:
- M.Sc. / B.Sc. in Microbiology or related life sciences
- 7–9 years of experience in microbiology within the API pharmaceutical industry
- Strong knowledge of aseptic techniques and contamination control
- Hands-on experience with microbiological instruments and testing methods
- Good understanding of regulatory guidelines and documentation practices
- Strong analytical and problem-solving skills
Preferred Skills:
- Experience in handling regulatory audits (USFDA/EMA inspections)
- Knowledge of data integrity and quality systems
- Familiarity with LIMS and laboratory software
Job Types: Full-time, Permanent
Pay: ₹35,000.00 - ₹55,000.00 per month
Benefits:
- Food provided
- Leave encashment
- Paid sick time
- Provident Fund
Experience:
- Microbiology: 3 years (Required)
Work Location: In person
