India Quality Assurance Specialist

3 days ago


Hyderabad Secunderabad Telangana, India beBeeQuality Full time

**Job Title:** Quality Assurance Specialist

The role of a Quality Assurance Specialist involves overseeing the implementation and maintenance of quality management systems. The successful candidate will be responsible for ensuring compliance with regulatory requirements, cGMP standards, GDP guidelines, and local regulations.

  • Implement quality management system in accordance with company policies and industry standards.
  • Develop procedures to align with cGMP, GDP, and local regulations.
  • Monitor operations of local distributors and stockists to ensure compliance with regulations.
  • Act as a liaison between internal and external customers on quality-related matters.
  • Support local testing and product launches.
  • Liaise with partners to manage day-to-day distribution operations.
  • Develop and maintain quality agreements with local distributors and partners.
  • Provide training to distributors and stockists on quality management practices.
  • Participate in GMP intelligence to review local regulations and industry standards.
  • Collaborate with risk management and product security teams on counterfeit and product diversion issues.
  • Interact with local regulators as needed.
Requirements

To be considered for this role, applicants must possess:

  • Pharmacist registration in India.
  • A valid practicing certificate as a pharmacist in India.
  • In-depth knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
  • Experience with quality management systems, including change control, deviation, validation, complaints, and audits/inspections.
  • Experience with commercial quality operations and third-party management.
  • Knowledge of distribution models and establishment of new entity procedures is an asset.


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