Quality Assurance Manager

Company Description

"THE SWASTIK PHARMACEUTICALS" is a renowned pharmaceutical company specializing in hand sanitizers, spirituous preparations, and general antiseptics since 1969. With a focus on quality and innovation, The Swastik Pharmaceuticals manufactures a range of pharmaceutical formulations for both human and veterinary use. The company's ultramodern facility is certified as per the latest GMP norms and complies with the latest Schedule-M procedures.

Location: Gannavaram, Andhra Pradesh

Key Responsibilities:
Quality Systems & Compliance

• Ensure compliance with the
  latest GMP and WHO
  guidelines in all QA activities.
• Review and approve
  SOPs, batch manufacturing records (BMR/BPR), protocols, and specifications
  .
• Conduct
  internal audits
  , support external audits, and ensure timely CAPA closure.
• Monitor quality metrics and drive continuous improvement initiatives.

Documentation & Batch Release

• Oversee
  batch documentation review
  , ensure accuracy, adherence to procedures, and compliance with regulatory norms.
• Coordinate with production, QC, and regulatory teams for
  timely batch release
  .
• Ensure good documentation practices (GDP) and maintain controlled documentation systems.

Deviation, Change Control & CAPA

• Manage and investigate
  deviations, OOS/OOT results
  , and ensure effective CAPA implementation.
• Initiate and evaluate
  change controls
  , ensuring regulatory and GMP alignment.

Shop Floor QA & Process Oversight

• Perform
  in-process checks
  and ensure compliance during manufacturing, packaging, and line clearance activities.
• Ensure manufacturing operations comply with validated processes and approved procedures.

Training & Development

• Conduct regular
  GMP and quality awareness training
  for cross-functional teams.
• Ensure alignment of teams with the latest regulatory expectations and best practices.