Senior Bio-Tox Scientist I

Summary :

The Senior Biocompatibility & Toxicology Scientist I will be responsible to ensure biocompatibility / toxicology related Quality and Regulatory compliance are met for all Hollister products. The position will support Hollister's biocompatibility and toxicology program (including policies and procedure).

Responsibilities :

• Solid fundamental understanding on biocompatibility series; ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, and biocompatibility assessment methodology.
• Standards and Regulations Knowledge / Capability - Ability to interpret current Bio / Tox standards, understands impact of external Bio / Tox standards requirements to internal Bio / Tox processes and procedures.
• Project Knowledge / Capability - Capability (with minimal guidance / support) to provide Bio / Tox related change control & NPC / SPRING project support as well as support / provide guidance to lower-level associates.
• Product Knowledge / Capability - Advanced knowledge related to Hollister product portfolio.
• Audit / Supplier Approval & Maintenance Knowledge / Capability - Capability (via audit support experience) to support Bio / Tox lab related supplier re-evaluations & qualifications. Additionally Capability to support external audits of Hollister (e.g. NSAI, FDA) with guidance.
• Complaint Management Knowledge / Capability - Capability to provide Bio / Tox support (with minimal guidance) to the complaint management process (including Bio / Tox related investigation support).
• Problem Solving Knowledge / Capability - Capability (without guidance) to support problem solving and root cause investigations for Bio / Tox laboratory test failures.
• Coaching & Mentoring Knowledge / Capability - Ability to receive and give feedback / guidance as well as on-the-job training to lower-level associates.
• Quality Systems Knowledge / Capability - Demonstrated basic knowledge of medical device quality systems (via 'functional lead' experience associated with a single 3rd party internal audit).
• Regulatory Process Knowledge / Capability - Demonstrated basic support capability (via direct 'functional lead' experience regarding a Regulatory submission related to a single external body).
• Financial Acumen Knowledge / Capability - Basic understanding of financial analysis related to lab testing as well as impact related to business case and Corporate Objectives. Additionally, basic understanding of the Company Purchase Order system (e.g. COUPA).

Essential Functions Of The Role :

Essential Functions Of The Role :

Work Experience Requirements :

Education Requirements :

Specialized Skills / Technical Knowledge :

Local Specifications (English And Local Language) :

Mode - Hybrid

Location - Gurugram

Skills Required

Audit Support