Sr Officer - MSTG

SUN PHARMA; Diu; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Sun Pharma is seeking a Senior Officer – MSTG in Dadara. The role involves coordinating with FDD, ADD, PDD, production, engineering, QA/QC, and other departments to ensure timely execution of new projects, planning trial and scale-up batches, and preparing essential regulatory and launch documents. The incumbent will also handle regulatory responses and investigations related to OOS/OOT and stability testing.

Educational requirement is M. Pharm. Experience range is 1–5 years.

Qualifications

• M. Pharm is required.

Responsibilities

• Coordinate with multiple departments (FDD, ADD, PDD, Production, Engineering, QA, QC, Supply chain, PM) for timely execution of new projects.
• Plan, monitor and support execution of trial, exhibit, scale-up/characterization, and process qualification batches.
• Prepare and review new product documents (MRF, master formula card, BOM, risk assessments, scale-up protocols, manufacturing records).
• Provide regulatory responses and technical justifications.
• Initiate gate passes for sample transfers across Sun Pharmaceutical sites.
• Prepare and review launch documents (MRF, product history, protocols, reports).
• Prepare, review and submit investigation reports for OOS/OOT and failures during stability testing.

Education

M. Pharm

Job description

Job Description:

Job Title

Senior Officer – MSTG

Business Unit

R&D1 Regulatory Affairs

Job Grade

G12B

Location :

Dadara

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.”

J ob 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 prepare, review and submit the investigation reports for OOS, OOT and any failure for exhibit/ validation/ commercial batch manufacturing and during stability testing.

Travel Estimate

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure 1- 5 years of experience.

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)

Requirements: