Executive

Job Title:

Executive

Business Unit:

Global Quality and Compliance

Job Grade

G12A

Location :

Dewas SGO

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:

• To prepare/review Cleaning Validation Protocol, Periodic and routine monitoring protocol and compilation of Report.
• Preparation and review of the analytical method validation protocol and report.
• Co-ordination for sampling and testing for cleaning validation/verification, periodic and routine monitoring for Block-A, B, C, Penem & Penem OSD (faropenem).
• Updating/review of cleaning validation matrix, evaluation for changes with respect to cleaning validation and closure of action items concerning cleaning validation.
• Data Collection for updation of cleaning validation matrix e.g. Measurement & calculation of equipment contact surface area.
• To Coordinate and perform the Visual inspection and swab sampler qualification of all the IPQA personnel involved in swab sampling activity.
• To ensure compliance and closure of the audit observations.
• To perform risk assessment on cross contamination for multiproduct facility considering the ADE/PDE values.
• To assist Production and IPQA personnel to perform gradient study to assess the impact of mechanical transfer and airborne as factor of cross contamination.
• To perform risk assessment using Failure mode effect analysis as tool for considering routes of cross contamination i.e. Mix up, Mechanical transfer, Air borne and Retention as risk factors for cross contamination.
• To identify the related CAPAs and actively participate in their timely closure, which will be outcome of above risk assessment
• Compilation of review report for Prevention of Cross contamination (yearly).
• Beta Lactam Containment Monitoring Co-ordination in Block-A, B, C, Penem, warehouse and Penem OSD (Faropenem).
• Prepare and maintain beta-lactam containment monitoring protocol.
• Review all results of beta-lactam containment monitoring as per the schedule
• Compilation of periodic report for beta-lactam containment monitoring.
• Overall evaluation of vendor by reviewing and approving vendor questionnaire, data provided by R & D, QC, vendor's audit and response sheet.
• Review and approval of vendor performance and annual review of Q –score/ audit schedule.
• Preparation of annual risk assessment for raw & packing materials.
• To maintain and archive the documents related to vendor management.
• To change the vendor status from provisional to approved in sap Hana.
• Preparation/updation/review of SOP
• Initiation & review of change controls related to vendor management, cleaning validation, cross contamination.
• To participate in implementation of CAPA/ Global CAPA related to cleaning validation, cross contamination and vendor management at site.
• To review and participate in case of any failure reported during cleaning validation/verification, cross contamination and vendor management for identification of root cause and its Corrective and Preventive action
• To prepare, review & approve risk assessment for elemental impurity.
• To prepare review & approve Annual Product Review.
• To prepare review & approve continuous process verification (CPV).
• To prepare, review & approve risk assessment for Nitrosamine impurity.

Travel Estimate

Job Requirements

Educational Qualification

B. Pharma / M. Pharma

Experience

Tenure:  4  – 7 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).