Quality Assurance Executive

Job Title: QA Sr. Executive – Pharmaceutical Manufacturing

Department:

Reports To:

Location:

Employment Type:

Job Summary:

The QA Executive plays a critical role in ensuring that all pharmaceutical products are manufactured in compliance with cGMP guidelines, regulatory requirements, and internal quality standards. The role involves overseeing production processes, documentation, audits, deviation handling, and supporting continuous quality improvements to ensure patient safety and product efficacy.

Key Responsibilities:

• Ensure compliance with

  GMP (Good Manufacturing Practices)

  and applicable regulatory requirements (e.g.,

  USFDA, MHRA, WHO, EU, TGA

  ).
• Review and approve manufacturing and packaging batch records, logbooks, and equipment qualification protocols.
• Monitor production and quality control activities to ensure alignment with SOPs and regulatory standards.
• Execution of Qualification / Validation Activity and Documentation.
• Conduct

  line clearance

  , in-process quality checks, and batch release documentation.
• Manage and investigate

  deviations, change controls, CAPA, OOS, and OOT

  cases.
• Participate in internal audits and support

  regulatory inspections

  by preparing documentation and responding to queries.
• Maintain QA-related documentation including

  SOPs, quality manuals, and validation reports

  .
• Review and approve

  Standard Operating Procedures (SOPs)

  and ensure their periodic revision and compliance.
• Participate in

  vendor audits

  and qualification processes for raw materials and packaging materials.
• Train staff on quality procedures, GMP guidelines, and hygiene practices.

Required Qualifications:

• Master’s degree

  in Pharmacy ( M.Pharm - QA) or related life sciences.
• Sound knowledge of

  GMP, ICH guidelines, regulatory compliance

  , and pharmaceutical documentation.
• Familiarity with

  QMS systems

  and electronic documentation tools (e.g., TrackWise, Master Control).
• Good understanding of equipment validation, cleaning validation, and process validation principles.

Key Skills:

• Strong analytical and documentation skills
• Attention to detail and accuracy
• Effective communication and teamwork
• Problem-solving and root cause analysis
• Knowledge of regulatory inspection protocols