Assistant Manager - Microbiologist

Job Description:

Job Title: Asst. Manager - Microbiologist.

Company : Concept Pharma. 

Location: Chikalthana MIDC, Chhatrapati Sambhajinagar.

Experience: 8–10 Years

Salary Budget: ₹Negotiable

Job Summary:

We are seeking an experienced and detail-oriented Microbiologist with 8–10 years of experience in the pharmaceutical industry. The ideal candidate should have strong expertise in microbiological testing, regulatory compliance, and must be FDA-approved. The candidate will be responsible for ensuring microbiological quality and compliance as per industry standards.

Key Responsibilities:

• Perform microbiological analysis of raw materials, finished products, and water samples
• Conduct environmental monitoring (EM) in cleanroom areas
• Carry out sterility testing and microbial limit testing (MLT)
• Prepare, maintain, and handle culture media and microbial strains
• Ensure compliance with GMP, GLP, and regulatory standards
• Maintain proper documentation as per FDA guidelines and audit requirements
• Participate in internal and external audits, including FDA audits
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results
• Maintain laboratory instruments and ensure calibration records are up to date

Required Skills:

• Strong knowledge of microbiological techniques and laboratory practices
• Experience in regulatory compliance (FDA, GMP, GLP)
• Good documentation and analytical skills
• Ability to handle audits and inspections effectively
• Strong team handling and coordination abilities

Qualification:

• B.Sc / M.Sc in Microbiology or relevant field

Mandatory Requirement:

• Candidate must be FDA approved