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Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.
https://www.bioconbiologics.com
Roles and Responsibilities
1. Minimum experience of 6 years and maximum of 12 years.
2. Sound knowledge of Biopharmaceutical Quality Management System.
3. Sound knowledge of Computer System Validation (CSV).
4. Hands-on experience with digital Quality Management System (QMS) platforms.
5. Experience facing regulatory inspections.
6. Strong interpersonal skills and ability to collaborate organization-wide.
7. Capability to work in a corporate quality setup; this position is in Corporate Quality Assurance (CQA).
8. Experience with Veeva Quality is an added advantage.
Primary job responsibilities include:
1. Quality enterprise system qualification.
2. Quality enterprise system master data management.
3. Quality enterprise system process owner and administration.
4. Handling quality management system records.
Note: Mandatory to have QMS and CSV experience.
Note: This job requires day to day interaction with end users to resolve their queries, assist them and provide amicable solutions.