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sun pharma industries
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Manager - DSE

Manager - DSE

sun pharma industries

6 - 10 years

15 - 16 Lacs

Gurugram

Posted:17 hours ago| Platform:

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Skills Required

toxicology Microbiology Risk assessment Biochemistry Monitoring ICH

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position:

Educational qualification:

Experience:

Desirable:

Experience of conducting animal toxicology studies (Genotoxicity studies, Repeat dose general toxicity studies etc. )

Determination of health based exposure limit (OEL and PDE).

Preparation of non-clinical dossier (as per CTD modules) for regulatory submission

Determination of health based exposure limit (OEL and PDE).

Preparation of non-clinical dossier (as per CTD modules) for regulatory submission

Risk assessment of process and degradation impurities, residual solvents etc. and to determine safe limit.

Safety evaluation for various excipients used in formulations and to determine safe limit.

Assessment of Extractables and Leachables.

Genotoxicity hazard assessment of starting materials, raw materials, intermediates, residual solvents, degradation products etc using (QSAR) softwares [according to ICH M7]

Toxicological evaluation of out of specification (OOS) of drug products for health hazard evaluation (HHE).

Environmental risk assessment (ERA) of drug products.

Assessment of nitrosamine impurities.

Active collaboration with cross-functional teams (CFTs).

Monitoring of out sourced non-clinical studies.

Other tasks, as directed by the manager(s) or determined during the annual objectives setting process.

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