Sr. Manager MSTG
4 days ago
Job Title:
Sr. Manager – MSTG NOSD
Business Unit:
R&D1 Regulatory Affairs
Job Classification Code:
New
Function:
Research & Development
Grade :
G9A
Location
Central India (Greenfield Project)
Key Responsibilities
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:
- Responsible for the MSTG-NOSD activity related Technology transfer of new products, site transfer products, commercial launches, LCM activities and CMO activities.
- Responsible for establishing new procedures, maintaining and updating existing procedures in the MSTG NOSD department.
- To co-ordinate with Cross Functional Team for execution of Trial, Scale-up, Exhibit, Process validation batches of new Products and commercial launch batches.
- Responsible for Support in regulatory Audit and Compliance & Query responses for Filed products.
- Handling & Support of Trouble shooting batches for data comparison and route cause Investigation for commercial products.
- Responsible for Review, comments and approval of MF, FMEA, RA, BMR & protocol (Sampling plan, Process validation protocol) and other technology transfer documents.
- Responsible for technical evaluation of new process technology in coordination with procurement team and finalization of User requirement specification.
- Technical support to plant operations team for upgradation to newer process technologies and better sterility assurance.
- Technical support for improvement in product robustness.
- Development of new vendors for process technologies.
- Responsible for overall development and training of the team members.
- To ensure compliance to cGMP and documentation for various packing activities.
Travel Estimate
Low
Job Scope
Job Requirements
Educational Qualification
B.Pharm / M.Pharm
Experience
Tenure: 14-17 Years (Pharmaceutical Industry experience with Injectable formulation site)
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).
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