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Job Title Senior Officer / Executive – MSTG Orals
Business Unit
R&D1 Regulatory Affairs
Job Grade
G12A/G12B
Location
Dadra
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Description
- To coordinate with different departments i.e. Formulation development (FDD), Analytical development (ADD), Packaging development (PDD), Production, Engineering, Quality control, Quality Assurance, Supply chain, Business development, Project management and any other department for timely execution of New projects.
- To plan, monitor and support for execution of the trial batch, exhibit batch, scale up/characterization batch and process qualification batches
- To prepare and review new product documents like material requirement sheet, master formula card, bill of material, risk assessment reports, scale up protocol and reports, exhibit/ trial batch manufacturing record and exhibit protocols and reports etc
- To provide the regulatory response and technical justification
- To initiate the gate pass for sample transfer at various sites of Sun Pharmaceutical Industries Limited
- To prepare and review approve new launch documents i.e. material requisition sheet, product history, trial/ characterization protocol and report, batch manufacturing record, process qualification protocol and reports etc
- To share process knowledge to cross functional departments through presentation for smooth technology transfer
- To review and evaluate product history and process parameters for technical remediation and improvement of product robustness
- To prepare and review investigation report/Justification report, additional activity protocol, regulatory evaluation etc
Travel Estimate
NA
Job Requirements
Educational Qualification
Graduate : M.Pharm
Experience
Tenure : 2 – 5 years
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).