Quality Control (QC)

5 years

4 - 5 Lacs

Posted:1 week ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

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 yearsLocation: PuneJobType: full-timeWe 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.

    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

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