AQA / Sr. Executive, Dy. Manager

8 hours ago

Hyderabad, India Aragen Life Sciences Private limited Full time

  1. Ensure Adherence and compliance to requirements of good manufacturing practices, GDP, EHS practices and company policies and procedures.

  2. Extending support to all the key functions to establish and effectively implement the quality system and procedures to maintain a state of compliance.

  3. review and approval of standard operating procedure, General testing procedure.

  4. issuance and maintain distribution of SOPs, Documents, analytical documentation for internal and external purpose and formats/registers/LNB required for analytical testing activities.

  5. review and approval of specification, MOA, Protocals(transfer/Miscellaneous), reports (Method validation/Transfer/miscellaneous), quality related documents and periodic audit trails of empower and standalone systems.

  6. handling of quality agreements and questionnaire received from contract laboratory qualification.

  7. responsible to handle internal, regulatory and customer audits and ensure compliance.

  8. ensure adherence to the data integrity principles.

  9. responsible to review and approval of the activities in electronic modules and defined in respective procedure(LMS, DMS, EDMS & QMS). responsible for assigning required trainings in respective LMS module.

  10. AQA, QMS, Analytical quality assurance.

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