Senior Officer, QualityAssr-ARPL-QAIP AR

3 weeks ago

Bengaluru 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

IPQA activities

Job Responsibilities

- Line clearance of various in process stage such as dispensing, granulation, compression, coating, sampling.
- Routine monitoring of all functional area to ensure adherence to the SOPs.
- Preparation and review of standard operating procedure.
- Performing in-process checks during manufacturing.
- Performing of AQL, collection of samples as applicable and trending of AQL.
- Sampling of SLED batches hold time study sample, in-process samples/finished product samples.
- Collection, storage, and disposal of reserve sample.
- Review of executed batch records and logbooks.
- Co-ordination for process validation and cleaning validation execution.
- Preparation for internal, customers & regulatory audits and making the compliance for the same.
- Coordination for internal, customers & regulatory audit compliance work.
- Works as a member of a team to achieve all outcomes.
- To perform swab/rinse sampling for the cleaning verification and validation programme, cleaning and verification of sampling thief's and accessories.
- Create a culture which values trust and provides the opportunity for employee development and growth in pursuit of our purpose and demonstrating our core values Collaboration, Courage, Perseverance and Passion.
- All other duties as assigned.

Job Requirements

- Education

- Bachelor of Pharmacy/ Science or any equivalent degree.

- Knowledge, Skills and Abilities:

- Should possess good communication and interpersonal skills along with computer efficacy in MS-Office and internet.
- Preparation, review of protocol & reports.

- Experience:

- Minimum 2 Years of experience in GMP regulated pharmaceutical 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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