Syngene MPharma Associate Scientist Job Opening, Apply Online
Syngene (www.syngeneintl.com) is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.
Mandatory expectation for all roles as per Syngene safety guidelines:
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to the development of procedures, practices, and systems that ensure safe operations and compliance to the company’s integrity & quality standards
- Driving a corporate culture that promotes the environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team, including self
- Compliance to Syngene’s quality standards at all times
- Hold self and their teams accountable for the achievement of safety goals
- Govern and Review safety metrics from time to time
Core Purpose of the Role
Working with BGRC Syngene in the field of regulatory toxicology.
- Conduct literature searches and prepare toxicological assessments of various raw materials/ingredients/API/Pharmaceuticals used in consumer and OTC products.
- Preparation and reviewing of Nonclinical overview for CTD submission of dossier filing.
- Creation of Toxicology Profiles for INCI ingredients as well as residual chemicals.
- Conduct risk assessment for raw materials for cosmetic applications including Margin of safety calculations.
- To derive Health Based exposure limit (PDE/OEL/DNEL/ADI) for Pharmaceuticals/cosmetics/nutraceuticals/agrochemicals/botanicals.
- To provide evidence of efficacy and safety (preclinical and clinical) as per regulatory requirements.
- Preparation of Safety Data sheet in compliance with GHS.
- Scientific literature search-To extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like TOXNET, HSDB, PubMed, Medline, ScienceDirect etc.
- To evaluate the quality of different toxicity studies (such as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reproductive and developmental toxicity, toxicokinetic studies) as per OECD/ICH/FDA/ISO guidelines.
- To prepare research reports/ dossiers according to the international regulatory guidelines.
All employees will consistently demonstrate alignment with our core values:
Educational Qualification: M.Pharma/M.Sc/MVSc
Experience: 3-6 years
Link to Original Notification to apply: Click here
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