Sr. Officer

3 days ago

Aurangabad, Maharashtra, India 997c6177-7e80-4b35-89eb-307c016f548d Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Roles and Responsibilities

  • Conduct BPR reviews, Change Control activities, Deviation investigations, Cleaning Validation, In-Process Quality Assurance (IPQA), Parenteral product validation, and Process Validation.
  • Ensure compliance with Good Manufacturing Practices (GMP) guidelines and maintain accurate records of quality control procedures.
  • Collaborate with cross-functional teams to resolve issues related to injectable products and parenteral manufacturing processes.
  • Develop and implement effective QMS systems to ensure adherence to regulatory requirements.
  • Provide technical support for APQR initiatives within the organization.

Desired Candidate Profile

  • 5-10 years of experience in pharmaceutical industry with expertise in BPR review, change control, cleaning validation, deviation investigation, injectables/inprocess quality assurance/ipqa/parenteral product validation/process validation.
  • Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Science (M.Sc.).
  • Strong understanding of GMP regulations and ability to apply them effectively in daily work.
  • Exposure of Regulatory Audits

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