Sr. Officer / Executive - MSTG

Sun Pharmaceutical Industries, Inc.; Dadra and Nagar Haveli; On-site; INR 500,000 - 800,000; Full time

Benefits offered by this job

Robust benefits

Opportunities for growth

Job summary

Sun Pharmaceutical Industries, Inc. is seeking a Senior Officer / Executive for their MSTG Orals team in Dadra. The role involves coordinating various departments to ensure timely execution of new projects, preparing and reviewing essential product documents, and providing regulatory responses. The ideal candidate should hold an M.Pharm degree with 2-5 years of experience. Join Sun Pharma, where your growth and well-being are prioritized, and contribute to impactful projects every day.

Qualifications

• 2 – 5 years of experience in a relevant field.
• Strong understanding of regulatory affairs.
• Good communication skills for cross-functional collaboration.

Responsibilities

• Coordinate with different departments for project execution.
• Plan and support execution of trial and scale-up batches.
• Prepare and review new product documents.
• Provide regulatory responses and justifications.
• Initiate gate passes for sample transfers.
• Share process knowledge for technology transfer.
• Review product histories for improvements.
• Prepare investigation and justification reports.

Skills

Coordination with departments

Regulatory response

Technical justification

Process knowledge sharing

Product robustness improvement

Education

Graduate: M.Pharm

Job description

Job Title

Senior Officer / Executive – MSTG Orals

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12A/G12B

Location

Dadra

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

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).