0 years

1 Lacs

Posted:23 hours ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Full Time

Job Description

QA & RA Officer – Pharmaceutical Company

We are looking for a QA & RA professional with pharmaceutical industry experience to handle Quality Assurance and Regulatory Affairs activities.

Key Responsibilities:

  • Ensure compliance with GMP, SOPs, and regulatory guidelines.
  • Prepare, review, and maintain QA documentation including SOPs, BMR, BPR, protocols, and reports.
  • Handle deviations, change controls, CAPA, and investigations.
  • Support internal and external audits and ensure timely audit responses.
  • Review batch records and ensure proper batch release documentation.
  • Coordinate with Production, QC, and other departments for quality compliance.
  • Handle Regulatory Affairs activities such as dossier preparation, submission, and follow-ups.
  • Ensure compliance with WHO-GMP, Schedule M, and other applicable regulations.
  • Maintain document control and ensure data integrity.

Requirements:

  • Experience in QA & RA within a pharmaceutical company is mandatory.
  • Strong knowledge of GMP, QMS, documentation, and regulatory requirements.
  • Good understanding of pharma manufacturing processes.
  • Ability to handle multiple tasks and meet timelines.
  • Good communication and coordination skills.

Job Types: Full-time, Permanent

Pay: Up to ₹180,000.00 per year

Benefits:

  • Cell phone reimbursement
  • Health insurance
  • Paid sick time
  • Provident Fund

Work Location: In person

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