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Quality Systems Specialist

1 week ago

Hyderabad, Telangana, India Aurigene Pharmaceutical Services Limited Full time

Quality Assurance Specialist:

We are seeking an experienced and skilled Quality Assurance Specialist to join our team at Aurigene Pharmaceutical Services Limited. The successful candidate will be responsible for implementing quality systems, corporate guidelines, and new initiatives within our organization.

Key Responsibilities:

  • Implement, monitor, and continuously improve quality systems to ensure compliance with regulatory requirements.
  • Maintain laboratory compliance and ensure inspection readiness at all times.
  • Investigate incidents in a timely manner and implement Corrective Action Preventive Action (CAPA) for all projects and general incidents.
  • Negotiate, approve, and monitor customer quality agreements to ensure compliance.
  • Qualify new business partners by following established procedures and audit/approve quality agreements.
  • Engage with customers, respond to queries, and facilitate quality team success in technology transfer and regulatory affairs.
  • Verify gate clearance documents, support DQA members, and perform internal and unannounced audits.
  • Presentation of quality issues, provision of training on cGMP, GDP, GLP, SOPs, and quality guidelines, and review/calibration schedules.

About You:

  • M.Sc./M.Pharm/Chemical Engineer/Ph.D. with 14-17 years of experience.
  • Preferably, experience in Analytical Development, Development Quality Assurance, or API Quality Assurance.

What We Offer:

  • A dynamic work environment with opportunities for growth and development.
  • A competitive salary package and benefits.
  • The chance to work with a talented team of professionals.