Senior Quality Assurance Specialist

1 week ago

Hyderabad, Telangana, India Lee Pharma Limited Full time
Job Description

We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Lee Pharma Limited.

The successful candidate will be responsible for ensuring the effective implementation of our Quality Management System (QMS) and maintaining compliance with relevant regulatory requirements.

Key Responsibilities:
  • Monitoring and reviewing vendor qualification processes and documents to ensure adherence to company standards.
  • Implementing and maintaining change control mechanisms to address all types of changes.
  • Reviewing and approving protocols and reports for process validation across all products.
  • Ensuring the review and approval of quality-related documents and formats.
  • Reviewing and approving BPCRs, specifications, methods of analysis, and SOPs for master approval.
  • Reviewing dispatch-related COAs, BPCRs, raw data before batch release.
  • Releasing intermediates/API as per market indent.
  • Maintaining calibrated critical equipment and ensuring effective systems for maintenance.
  • Testing materials and reporting results.
  • Monitoring QMS activities.
  • Compliance monitoring during customer audits.
  • Reviewing and approving cleaning validation reports.
  • Approving analytical method validation, verification, and transfer protocols, reports, and raw data.
  • Reviewing and approving raw data for raw materials, intermediates, recovery solvents, finished products, and stability samples.
  • Qualifying equipment, facilities, and utilities.
  • Reviewing risk assessment reports.
  • Monitoring customer complaints and returned goods.
  • Monitoring CAPAs.
  • Mock recalls and recall management.
  • EHS document review.
  • Supporting RA for registrations, response to deficiencies, and queries.
  • Performing external audits for vendors, contract labs, and service providers.
Requirements

We are looking for a candidate with a strong background in quality assurance, excellent communication skills, and the ability to work independently. The ideal candidate will have:

  • Bachelor's degree in a relevant field (e.g., chemistry, biology, engineering).
  • Minimum 5 years of experience in a quality assurance role.
  • Proven track record of ensuring compliance with regulatory requirements.
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills.
Compensation

We offer a competitive salary package, including an estimated annual salary of ₹12,00,000 - ₹18,00,000 depending on experience.

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