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.