Biocon Biologics
Location
Bangalore | India
Job description
Role/Job Description
· Accountable for all India Quality Control - Microbiology operations
· Accountable for defining and implementing processes for on time delivery and operational excellence.
· Accountable for managing Team performance and deliverables.
. Lead and drive Quality Control – Microbiology activities and ensuring products are tested with validated methods in a timely, cost-effective, efficient, and fully compliant manner.
· Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
· Drive effective decision making and troubleshooting of methods and reconciliation of atypical results.
· Adherence to project timelines.
· Define, implement, and monitor appropriate metrics, relentlessly seeking and implementing best practices.
· Provide guidance on enhancement of sterility assurance and contamination control.
· Effective communicator of ideas, organization goals and results to team members across cross-functional roles and departments.
· Define and implement a strong organizational structure to address customer needs
· Develop and coach the team while effectively managing team performance.
· Closely interact with all business functions to ensure effective contribution to BBIL goals , including continuous supply of products to market, launches, and submissions
· Lead cross-functional initiatives, proactively support other QLT members where needed
· Represent Global Quality at cross-functional leadership meetings, and committees, as necessary
Technical / Functional Skills:
· Experience and expertise in the EM, Aseptic processing & Sterility Assurance
· Experience with analytical method development, transfer, and validation for drug substance and drug product release and stability testing is required.
· Extensive experience in facing regulatory audits and knowledge of governing regulations and GMPs is required
· Good understanding of Lean principles (Green Belt certification preferred)
Behavioral / Management / Other Skills:
· Strong leadership and decision making skills.
· Effective communication and presentation skills to achieve organizational change overcoming resistance and barriers
· Critical thinking, attention to detail, ability to articulate ideas
· Be self-motivated and organized
· Ability to work under pressure and cope with multiple priorities
BACKGROUND AND EXPERIENCE REQUIRED:
· M. Sc./Ph.D./Pharm.D. or equivalent in a relevant scientific discipline
· 15-20 years of experience in multinational pharma/biopharma companies, with strong background in Microbiology/ Biotechnology, Biochemistry and significant exposure to EMA and US FDA requirements
.Experience in managing large teams
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