Senior Officer, QualityAssr-ARPL-QAIP AR

1 month ago

Bengaluru, India Apotex 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.
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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 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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