Biocompatabilitiy and Toxicology Scientist

Core Staffing Solutions

3 - 8 years

5 - 13 Lacs

gurugram

Posted:1 month ago| Platform:

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Skills Required

toxicology biocompatibility

Work Mode

Hybrid

Job Type

Full Time

Job Description

Role & 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 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 (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.
Demonstrates fundamental understanding on biocompatibility series; ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, and biocompatibility assessment methodology.
Knowledge in Quality Systems standards and FDA Medical Device Regulations (i.e., ISO 13485; QSR).

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