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Eurofins It Solutions India
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Manager/Group Leader- E&L

Manager/Group Leader- E&L

Eurofins It Solutions India

16 - 18 years

|

7 - 8 Lacs

bengaluru karnataka india

Posted:2 days ago| Platform: Foundit logo

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Skills Required

leadership team management extractables and leachables (e&l) iso guidelines lc-ms/ms gc-ms/ms

Work Mode

On-site

Job Type

Full Time

Job Description

Key Responsibilities:

Lead and manage a team of 10+ scientists (Ph.D. and M.Sc.) ensuring scientific excellence and operational efficiency.
Extensive knowledge and application of Extractable and Leachable (E&L) testing in compliance with USP monographs and ISO guidelines for medical devices.
Oversee operation and maintenance of multiple analytical instruments including LC-MS/MS, GC-MS/MS, ICP-MS, and Ion Chromatography.
Lead method development and validation on LC-MS/MS, GC-MS/MS, and ICP-MS platforms.
Prepare, review, and implement Standard Operating Procedures (SOPs) related to E&L, laboratory processes, and best practices.
Ensure compliance with 21 CFR Part 11, data integrity principles, and good documentation practices within a cGMP laboratory environment.
Monitor and manage daily laboratory operations, workflow, and resource allocation.
Review and approve SOPs, Certificates of Analysis (COA), and other quality documentation.
Utilize analytical techniques (NMR, IR, HPLC, GC, LC-MS) for structural elucidation and interpretation of results.
Provide training, mentorship, and conflict resolution to foster a collaborative and high-performing team environment.
Promote laboratory safety and ensure adherence to Safety, Health, and Environmental (SHE) standards.

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Eurofins It Solutions India

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