Quality Control (QC)

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.

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.

Qualifications & Skills:

• 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.

Preferred Experience:

• 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.