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IT & Software
Biocon Biologics Looking for Info Tech – CSV SME at Bangalore Full Time
Job Description
About the company:
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 believesthat strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of liv
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About the company:
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 believesthat 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.
Qualifications
1. 8-10 years of experience in IT
2. Experience in SDLC processes, Quality Control, Quality Assurance, Computer Systems Validation and GxP Compliance
3. Deep expertise in 21 CFR Part 11, EU Annex 11, GAMP5 guidance.
4. Excellent document writing and reviewing skills specifically with experience in Pharmaceutical CSV documentation
5. Experience in qualifying IT CSV tools such as HP ALM, Validator, Valgenesis
6. Experience in internal/external audits and inspections (Conducting as well as responding to)
7. Experience working with technical teams, OEM product teams and other project stakeholders to gather inputs on CSV deliverables (ERES Assessments, Risk Assessments, Plans and Summary reports, QMS Events, Deviations, CAPA, Change Controls, Periodic Review Reports)
8. Ability to deal with uncertainties and navigating through ambiguities
Job Description
1. The CSV Specialist will serve as an SME and assist the IT System Owners in managing the CSV deliverables.
2. Author Validation Plan and Validation Summary reports
3. Provide guidance in drafting ERES Assessments, Risk Assessments, Plans and Summary reports, QMS Events, Deviations, CAPA, Change Controls, Periodic Review Reports
4. Support multiple projects in parallel.
5. Assist the ITQA leads and IT System Owners during inspections and remediation efforts
Desired
1. Proactively identify risks and opportunities for improvement, define solution strategies
2. Review operations and related controls provide assistance to Author applicable SOPs governing the CSV processes for BBL IT
