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Quality Control Executive

2 weeks ago

Pune, Maharashtra, India Weekday AI Full time ₹ 9,00,000 - ₹ 10,00,000 per year

This role is for one of the Weekday's clients

Salary range: Rs Rs ie INR 9-10 LPA)Min Experience: 6 years

Location: Pune

JobType : full-time

We are seeking an experienced and detail-oriented Quality Control Executive with a strong background in microbiology and pharmaceutical quality practices. The ideal candidate will have hands-on expertise in microbiological testing, culture preservation, microscopic analysis, and adherence to Good Manufacturing Practices (GMP) and GxP standards. This role requires an individual with proven skills in media preparation and consumption monitoring, as well as a comprehensive understanding of regulatory compliance in a fast-paced manufacturing environment. The candidate will play a pivotal role in ensuring product safety, quality, and compliance with both internal and external regulatory requirements.

Requirements
Key Responsibilities
  • Conduct microbiological quality control testing including microscopic count, microbial limit tests, and sterility assessments to ensure product quality.
  • Perform and oversee culture preservation techniques to maintain reference strains and ensure availability of reliable microbial cultures for routine testing.
  • Ensure accurate preparation, validation, and utilization of culture media, including monitoring of media consumption and ensuring compliance with laboratory inventory requirements.
  • Implement and strictly adhere to GMP, GxP, and other regulatory guidelines, ensuring that all microbiological activities are conducted in compliance with international standards.
  • Maintain detailed documentation of laboratory results, standard operating procedures (SOPs), and quality control records in alignment with audit and regulatory expectations.
  • Assist in method development and validation for microbiological testing procedures, ensuring robustness and reproducibility.
  • Ensure calibration, qualification, and routine maintenance of laboratory equipment, including microscopes, autoclaves, incubators, and microbial detection systems.
  • Train and mentor junior QC staff in best practices related to microbiological testing, documentation, and compliance.
  • Actively participate in internal and external audits, regulatory inspections, and continuous improvement initiatives to enhance laboratory performance and compliance.
  • Collaborate cross-functionally with production, R&D, and quality assurance teams to address microbiological quality issues, deviations, or out-of-specification results.
  • Monitor and analyze laboratory data, preparing reports and presenting findings to management for decision-making.
  • Drive continuous improvement in QC processes, ensuring accuracy, efficiency, and cost-effectiveness in microbiological operations.
Required Skills & Competencies
  • Strong knowledge and hands-on experience in quality control microbiology.
  • Expertise in microscopic count methods and related microbial analysis techniques.
  • Proficiency in culture preservation techniques for long-term microbial strain stability.
  • In-depth knowledge of GMP, GxP, and regulatory requirements relevant to pharmaceutical/biotechnology industries.
  • Skilled in media preparation and media consumption tracking, with ability to optimize utilization.
  • Strong documentation and reporting skills, with attention to detail and compliance orientation.
  • Ability to troubleshoot laboratory issues and propose corrective and preventive actions (CAPAs).
  • Strong communication, leadership, and training abilities to guide junior staff and ensure team alignment.
  • Familiarity with laboratory information management systems (LIMS) and electronic documentation is preferred.
Qualifications
  • Master's degree in Microbiology, Biotechnology, or related life sciences discipline.
  • 6–8 years of proven experience in quality control microbiology within pharmaceutical, biotechnology, or related industries.
  • Demonstrated track record of working in compliance with international standards such as USFDA, EMA, or WHO GMP guidelines.