Executive, Quality Assuranc-ARPL-AQAR AR

4 weeks ago

Bengaluru, Karnataka, India Apotex Inc. Full time
Job Description

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

Job Summary

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

Job 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, CAPAs, Non CAPA Follow-up task and LIRs.
- 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 ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma 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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