Job Description

  • Lead and maintain the Pharmaceutical Quality System (PQS) by establishing, implementing, monitoring, and continuously improving quality systems in compliance with ICH Q7, ICH Q9(R1), ICH Q10, applicable cGMP regulations, and company quality policies to ensure a state of continuous regulatory compliance.
  • Should be very much conversant with the implementation and monitoring of computerized systems validation (CSV), Caliber LIMS/QMS/DMS.
  • Provide independent Quality Unit oversight to the plant for all GMP operations, including manufacturing, warehousing, laboratories, engineering, validation, utilities, computerized systems, contract service providers, and supply chain activities, ensuring quality decisions remain independent of operational and commercial influences.
  • Authorize/do the release or rejection of APIs, intermediates, raw materials, packaging materials (where applicable), and quality records after...

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