QA Executive

QA Executive

Pharmaceutical ManufacturingDepartment:

Reports To:

Location:

Employment Type:

Job Summary:

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.
• 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:

• Masters 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, MasterControl).
• 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