Website Sun Pharma ltd
Post Name: Senior Officer – MSTG
Business Unit: R&D1 Regulatory Affairs
Job Grade: 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 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.
