15 - 20 years

12 - 14 Lacs

Posted:1 week ago| Platform: Foundit logo

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On-site

Job Type

Full Time

Job Description

Job Title:

Industry:

Job Location:

Experience Required:

Salary:

Education:

Key Skills Required:

  • Strong knowledge of data integrity principles
  • Hands-on experience with instruments like HPLC, GC, and UV
  • Experience in cleaning validation and microbiological testing
  • Familiarity with incident investigations and regulatory compliance

About the Company:

  • A leading API pharma manufacturing group known for its strong global presence and commitment to quality and innovation.

Job Responsibilities:

  • Lead and manage the Quality Control (QC) department to ensure quality at every stage of manufacturing and testing.
  • Oversee sampling, inspection, and testing of raw materials, packaging materials, in-process, and finished products.
  • Ensure timely release or rejection of batches based on quality data.
  • Handle stability chamber management, testing, and shelf-life evaluations as per protocol.
  • Conduct microbiological analysis for raw materials, finished goods, water, and environmental monitoring.
  • Review trends in physicochemical and microbiological test data for compliance.
  • Manage out-of-specification (OOS), deviation investigations, and analytical support for product recalls and complaints.
  • Coordinate with QA and R&D on specifications, analytical procedures, and validations.
  • Ensure equipment/instrument qualification, calibration, and preventive maintenance.
  • Maintain and audit QC records, reference/working standards, and ensure data integrity systems are in place.
  • Supervise glassware cleaning, protocol validation, and implementation of cleaning procedures.
  • Plan and execute internal audits and ensure compliance with GLP and GMP standards.
  • Review and validate SOPs, protocols, and test methods (pharmacopeial & in-house).
  • Support employee training in alignment with cGLP and cGMP practices.
  • Evaluate change control proposals, failure investigations, market complaints, and implement improvements in QC systems.
  • Ensure all activities follow company reporting systems and regulatory expectations.

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