qa - am/dm

3 weeks ago

Baddi, India Lyra Laboratories Pvt Ltd Full time

Job description

Responsibilities:

  • Lead and support the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS).
  • Review and approve Standard Operating Procedures (SOPs) relevant to the QA department.
  • Develop and implement QA-related SOPs in alignment with regulatory and organizational standards.
  • Oversee the review, approval, issuance, and control of Batch Manufacturing Records (BMRs).
  • Monitor batch quality and ensure BMR compliance.
  • Authorize and release finished batches after thorough quality checks.
  • Conduct and review investigations related to batch deviations, Out of Specification (OOS) results, and other non-conformances.
  • Ensure effective implementation and closure of Corrective and Preventive Actions (CAPA).
  • Review and approve raw material (RM) quality data, including RM vendor audits and approvals.
  • Promote preventive measures to avoid recurrence of deviations, OOS, and related issues.
  • Coordinate and support audits by customers and regulatory agencies, ensuring timely closure of audit observations and full compliance with regulatory requirements.

Qualification:

Experience: 5-9 years

Location: Baddi

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