Senior Executive - Biotechnology DQA (Tandalja)

Job Title: Senior Executive – Biotechnology (DQA) Business Unit: R&D1; Regulatory Affairs Job Grade G11B Location : Vadodara 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 Job Description: Key Responsibilities:
- Responsible for lifecycle management of development products with respect to knowledge management and lifecycle management as per ICH. Management of process changes in early phase development
- Review of clone development and cell banking documentation and ensuring regulatory compliance in plans and reports
- Review of product development documents such as process development reports, process descriptions, process control strategy documents etc.
- Review of analytical developments such as method development reports, method qualification/validation protocols and reports and ensure compliance as per latest quality and regulatory requirements
- Development, Implementation and continual improvement of Quality Management System at R&D; through SOPs, Manuals, training and audits and ensuring alignment with corporate QA and site QA.
- Verification of Laboratory data and its integrity, ensuring good documentation practices and data reporting as per ALCOA++
- Compilation and review of process and analytical documents for regulatory filing and CMC review Travel Estimate NA Job Requirements Educational Qualification Qualification : M.Pharm /M.Sc Experience Tenure: 5 – 7 years of relevant experience Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust advantages 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). Apply on Kit Job: kitjob.in/job/4n9k7l