General Business Manager

2 days ago

Nellore, Andhra Pradesh, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Title:

Senior Operations Manager

About the Role:

The Senior Operations Manager will oversee and direct the Quality Assurance function at the manufacturing site, ensuring compliance with cGMP, regulatory requirements, and internal quality standards for oral liquids and tablet formulations.

Key Responsibilities:
  • Quality Systems Management:
    • Ensure robust implementation and maintenance of QMS (Quality Management Systems) in line with ICH, USFDA, EU, and other global regulatory requirements.
    • Oversight of deviations, CAPAs, change controls, and risk assessments.
    • Review and approval of site-specific SOPs, master documents, validation protocols, and reports.
  • Regulatory Compliance:
    • Ensure readiness for and manage regulatory and customer audits (e.g., USFDA, MHRA, ANVISA, WHO, TGA).
    • Lead audit preparation, execution, response, and follow-up activities.
    • Maintain compliance with data integrity and electronic documentation practices (21 CFR Part 11).
  • Leadership & Team Management:
    • Direct and mentor the QA team, fostering a culture of compliance and continuous improvement.
    • Develop training plans and oversee periodic training of QA and cross-functional teams.
  • Documentation & Records:
    • Final QA approval for BMRs/BPRs, batch release documentation, and CoAs.
    • Oversight of document control, archival, and retrieval in compliance with regulatory requirements.
  • Product Quality & Market Support:
    • Oversee product quality reviews (APQR/PQR).
    • Evaluate and support investigation of customer complaints and product recalls, if any.
    • Work closely with QC, Production, and Regulatory Affairs to ensure quality alignment across functions.
  • Validation & Qualification:
    • QA oversight of equipment qualification, process validation, cleaning validation, and analytical method validation.
Requirements:
  • Education: B.Pharm / M.Pharm / M.Sc. in a relevant discipline.
  • Experience: Minimum 16 years in pharmaceutical QA, with significant leadership experience in regulated markets.
  • Proven experience in handling regulatory inspections (USFDA, EU, etc.).
  • Strong knowledge of cGMP, ICH Q-series guidelines, and data integrity principles.
  • Exposure to both oral liquids and solid dosage forms is a must.

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