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Contribute to the development and implementation of new safety-related systems, processes and procedures within the process. TCS

You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments

Review QMS documents, SOPs, processes and records for compliance with GMP requirements; Support OOS, OOT, deviations, change controls, CAPA, risk assessments and investigations; Ensure compliance with ALCOA+ data integrity principles

Bachelors degree in life science/ pharmacy/ health related field with strong attention to detail and working knowledge of Excel and Word

To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.

Assist in day-to-day production activities as per SOPs. Conduct basic chemical handling, mixing, and batch processing. Monitor production processes and record process parameters.

Knowledge about troubleshooting and experience in handling FETTE & SEJONG compression machines. Required exposure in regulatory audits. 

Cross-Functional Collaboration: Work closely with Regulatory, International Export, Marketing, and R&D teams to streamline the flow of information and ensure project alignment.

Graduate degree in Science B.pharm, Life Sciences, Biotech, Zoology, Botany, etc. with PG Diploma in Clinical Research is mandatory with minimum 1 years’ experience in Clinical Trials is desirable.