About this role
Job Title:
Executive - MSTG
Business Unit:
R&D II, Regulatory Affairs And Global Pharmacovigilance
Job Grade
G12A
Location :
Pithampur
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.”
- Review of transferring site documents like MBMR, change controls, MF, process validation protocols/reports and detailing of each product that needs to be transferred to Greenfield site for each filling line. It also includes identifying any critical aspects/requirements of each product/process and including same in the scope.
- Based on identification of line wise product, review of layouts for General Injectable block and Cyto Injectable block at Greenfield location with Cross functional team as per current CGMP, USFDA, Annex-1 and local regulatory requirements.
- Technical evaluation finalization for all process equipment’s such as Filling machine, Isolators, Manufacturing Skid, Autoclave, Lyophilizer with ALUS, Bung Processor, Leak Testing, Automatic Visual Inspection, etc. with respect to process/product requirement.
- Review of design documents for processing equipment’s such as URS, P&ID, Design Qualification, Installation Qualification, Operational Qualification, Software Design Specification, Hardware Design Specification, 3D Drawing, etc.
- Review of utility basis on review of document package of each product for General Injectable block and Cyto Injectable block.
- Ensure efficient collaboration and co-ordination between relevant departments like Warehouse, Engineering, PPIC, Quality Control, Quality Assurance, Procurement and Management for project execution.
- Co-ordinate for filter validation activity and alternate vendor for routine production consumables like filters and tubing for Greenfield. Review filter validation protocols (questionnaire) and reports in co-ordination with CFT members.
- Implementation of automation and digital recording systems.
Travel Estimate
NA
Job Requirements
Education Qualification
M. Pharma
Experience
Tenure : 6+ 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).