Job Description

:
This role is for one of the Weekday's clients
Salary range: Rs 400000 - Rs 500000 (ie INR 4-5 LPA)
Min Experience: 5 years
Location: Pune
JobType: full-time
We are seeking an experienced and detail-oriented Quality Control (QC) professional with a strong background in microbiology to join our team. The ideal candidate will be responsible for ensuring the microbiological quality of raw materials, in-process samples, and finished products. A critical part of this role involves inoculum development, culture preservation, performing microscopic counts, and maintaining comprehensive quality control documentation. The candidate must bring 5-7 years of relevant experience in microbiology QC, preferably in pharmaceutical, biotech, or fermentation-based industries.
Requirements:
Key Responsibilities:

• Inoculum Development:

• Prepare and maintain high-quality inoculum batches for production.
• Ensure the viability, purity, and consistency of inoculum through routine monitoring and testing.
• Optimize inoculum protocols for specific strains and production needs.

• Microbiological Quality Control:

• Conduct routine microbiological testing of raw materials, intermediates, and final products.
• Perform environmental monitoring and bioburden testing as per regulatory and internal standards.
• Identify and report microbial contamination and deviations, and support root cause analysis.

• Microscopic Count and Analysis:

• Perform and record accurate microscopic counts using standard procedures (e.g., haemocytometer or cell counter).
• Interpret microbial morphology and characteristics under the microscope.
• Maintain consistency and precision in microbial enumeration.

• Culture Preservation and Strain Maintenance:

• Maintain microbial culture collections through methods like lyophilization, cryopreservation, or serial sub-culturing.
• Ensure the genetic stability and integrity of preserved cultures.
• Maintain proper inventory and storage of microbial strains.

• Quality Control Documentation:

• Maintain meticulous and timely records of all QC activities in accordance with cGMP and internal SOPs.
• Prepare QC reports, deviation logs, CAPAs, and batch release documentation.
• Participate in audits and inspections, providing all required documentation and data support.

• Bachelor's or Master's degree in Microbiology, Biotechnology, or a related field.
• 5-7 years of hands-on experience in a microbiology quality control role.
• Proficient in inoculum development techniques and microbial culture handling.
• Experience with microscopic counting methods and microbial enumeration.
• Solid understanding of microbial culture preservation techniques.
• Well-versed in documentation practices aligned with GMP and regulatory standards.
• Strong analytical, observational, and problem-solving skills.
• Good communication skills and ability to work collaboratively in a cross-functional environment.

• Prior experience in fermentation, biopharmaceuticals, or industrial microbiology.
• Familiarity with ISO standards, FDA, and other regulatory requirements for microbiological QC.
• Experience with audit preparedness and QA-QC collaboration.