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:
Initation, 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 BMRs/ECRs along with necessary data as per the production requirement of modules at Toansa Site.
Preparation of investigation report of OOS/UPD/PQC of all the product manufactured in all the Production modules.
Uploading of draft BMRs/ECRs in BPR printing module for implementation and release.
Preparation, review and QA approval of validation /qualification protocols,reports,PPV,SPR,Tempeature 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 of supporting data / documents data CCRs / Validation / Qualification related activites to complete the record as per the requirements.
Tracking the completion of Activites as per the actions items for closure CCRs/ Protocols the dues data. Whatever applicable, provide suitable justification for extension of records in the Trackwise.
To prioritize CCRs/ Validation/ Qualification related work to align with the production commitments.
To Harmonize Documentation practice related to CCRs , Validation & qualification activites at sites .
To ensure good quality documentation work as per GDP so as to minimize document review and approval time. Maintain very good productivity level all assigned documentation related activites.
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 training in LMs.
Responsible for all training related to Document cell.
To assign training activites to Job Roles.
TO review completion of Job Specific Trainings (as applicable).
Responsible for organizing Training session in department, creating the training session 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
M.Sc Chemistry & B.E Chemical
Experience
8 years to 10 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).