Assistant Manager

1 hour ago

Haridwar, Uttarakhand, India Ravian Life Science Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Role & responsibilities

  • Oversee implementation and adherence to CGMP and quality management systems (QMS) across departments.
  • Review and approve batch manufacturing records (BMR), batch packaging records (BPR), and standard operating procedures (SOPs).
  • Handle deviations, change controls, CAPA, OOS/OOT investigations**, and ensure timely closure as per internal SOPs.
  • Coordinate with cross-functional teams (Production, QC, Regulatory, Engineering) to maintain quality compliance.
  • Participate in internal and external audits, including regulatory inspections.
  • Monitor and support activities related to validation and qualification.
  • Conduct periodic GMP training and awareness programs for plant staff.
  • Ensure documentation control, data integrity, and compliance with applicable regulatory standards.
  • Assist in vendor qualification, raw material specifications review, and quality risk management.
  • Prepare and submit quality reports, audit responses, and periodic reviews to senior QA management.

Candidate profile

  • Bachelor's or Masters degree in Pharmacy, Chemistry, or related field.
  • 8 - 12 years of experience in QA in the pharmaceutical industry.
  • Sound knowledge of GMP guidelines, and pharmaceutical regulatory requirements.
  • Strong analytical thinking, attention to detail, and decision-making skills.
  • Proficient in documentation, MS Office, and audit compliance tools

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