Biocon Biologics | IT Q&C Audit Compliance Manager | india
1 week ago
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 organisation 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, US and Japan. Biocon Biologics has a product pipeline of 28 molecules. Biocon Biologics believes that strong partnership offers enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.
Key Responsibilities
- Lead IT audit and compliance function within IT Quality and compliance team.
- Primary responsible for enterprise system Audit readiness and compliance
- Information security ISO 270001 SPOC for BBL IT
- Manage multiple priorities (Projects, Operations, Audits, Periodic Reviews)
- Represent IT during inspections and remediation efforts
- Proactively identify risks and opportunities for improvement, define solution strategies and roadmaps
- Review and approve Validation documents
- Lead the Project Milestone Reviews to review all projects and approve Milestone Transitions Author, Review applicable SOPs governing the processes for BBL IT
Qualifications
- 12+ years of experience in IT. 8-10 years in Pharmaceutical Industry CSV, Quality and GxP Compliance roles
- Deep expertise in implementing 21 CFR Part 11, EU Annex 11, GAMP5 guidance.
- Experience managing internal/external audits and inspections.
- Strong verbal communications skill managing global stakeholders.
- Experience in CAPA management, Quality metrics and reporting.
- Deep expertise in SDLC processes, ITIL processes, Testing, Computer Systems Validation and GxP Compliance
- Experience managing Senior stakeholder expectations.
- Ability to deal with uncertainties and navigating through ambiguities.
- Experience in Pharma manufacturing or Quality and clinical is preferred.
Equal Opportunity Employer
Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorisation and employment eligibility verification requirements of the Immigration and Nationality Act.
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