Executive, Quality Assuranc-arpl-aqar Ar

1 week ago

Bengaluru, Karnataka, India Apotex Research Private Limited Full time

About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

Job Summary:

Responsible for Review of Analytical Documents (Stability Reports/SFG/IP/FP/RM/PM).

Responsibilities:

  • Responsible for Successful Health Authority inspection.
  • Responsible to review of analytical documents like Commerical stability, IP,SFG,RM,PM.
  • Responsible to review of qualification reports for laboratory instruments.
  • Responsible to review of calibration reports for laboratory instruments.
  • Responsible to review of working standard reports.
  • Review of analytical documents generated by laboratories.
  • Responsible to review of Deviations, Lab event, Temporary Changes, CAPA's, Non CAPA Followup task and LIR's.
  • Responsible to review/verification of analytical data through LIMS.
  • Responsible for completion of training prior to execution of any activity.
  • Documentation control: Resposnible for submitting the documents for archival and updation of documentation as per SOP.
  • To provide, execute and impart training with respect to procedures review and updation.
  • To be responsible for all activities in the Quality Assurance, including cGMP/ cGLP/ cGXP, documentation and implementation of departmental quality systems.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other duties as assigned.

Job Requirements:

-
Education

  • Minimum Bachelor of Pharmacy/ Science or any equivalent degree
-
Knowledge, Skills and Abilities

  • Good knowledge in day to day pharma updation
  • Good Management qualities
  • Vigilance at work
-
Experience

  • Minimum 2 years of experience in GMP Regulated industry


At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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