Senior Officer

Company: Sun Pharmaceutical Industries Ltd Job Title: Senior Officer Business Unit: Production (Docs Cell) Job Grade G12B Location : Toansa 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.” Key responsibilities: Initiation, review and QA approval of change controls related to process, equipment and facility in TrackWise system for all the modules/Dept. to fulfill the production requirement at Toansa site. Preparation of draft MPRs/BRCs along with necessary data as per the production requirement of modules at Toansa site. Uploading of draft MPRs/BRCs in BPR Printing Module for implementation and release. Preparation, review and QA approval of validation/qualification protocols, reports, PPV, SPR, temperature mapping, product manuals, plant development reports, Cleaning matrix, CPDR, Equipment suitability, HAZOP, Investigations (OOS/OOT/UPD) as per current SOPs for all the production modules at Toansa site. To coordinate with Production modules effectively for collection of supporting data / documents for CCR / Validation / Qualification related activities to complete the record as per the requirement. Tracking the completion of the activities as per the actions items for closure of CCRs/Protocols as per the dues dates. Wherever applicable, provide suitable justification for extension of records in TrackWise. To prioritize CCRs/Validation/Qualification related work to align with the production commitments. To harmonize documentation practices related to CCRs, Validation & Qualification activities at site. To ensure good quality documentation work as per GDP so as to minimize document review and approval time. Maintain very good productivity level in all assigned documentation related activities. Escalate any delays/bottleneck in completing documentation work to the concerned operating manager and team leader. Practicing company values in all aspects of work. Ensuring compliance to cGMP, current SOPs and Safety procedures, as applicable, in the related areas. Adherence to schedules to avoid any deviation and ensure for compliance. Ensuring timely completion of assigned trainings in LMS. Responsible for all training related to Document Cell. To assign Training activities to Job Roles. To review completion of Job Specific Trainings (as applicable). Responsible for organizing training sessions in department, creating the sessions in LMS and punching the attendance in system. Maintaining all record related to training. Tracking pending trainings and ensuring training completion through continuous follow-up. Job Requirements Educational Qualification Experience Tenure : 5 - 8 Years in API Plant, Strong knowledge of cGMP, FDA regulations, and industry best practices 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). #J-18808-Ljbffr Sun Pharmaceutical Industries, Inc.