Title:  Senior Executive

Job Title:

Executive / Sr. Executive QA

Business Unit:

Global Quality & Compliance

Job Grade

G12A / G11B

Location :

Ahmednagar / Ahilyanagar

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:

• Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review/verification to ensure adequacy, completeness and compliance of documents, procedure. practices, etc.
• To monitor, tracking, review & closure of deviations, Out of specification, Investigations. Corrective and Preventive actions, Market complaint. Change controls, etc. to ensure adequacy in quality management system (QMS).
• Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software. To escalate or highlight problems in QMS document and investigation in time.
• Review of data with evaluation to support of QMS documents like Change controls, deviations, CAPAS, OOS, Laboratory Events & monitoring of Preventive Maintenance, qualification etc.
• Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, etc.
• To provide the required details/data related to QMS for the preparation of APQR, monthly report and as and when required. Preparation/review of APQR
• Preparation/guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities, received / manufactured material, related to audit compliance, failure/gaps of existing system, activities related to laboratory controls, etc.
• Review of change controls received from different departments (viz. process, equipment, facility. SOP, specification, etc.) for its appropriate evaluation, justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise.
• Providing the status of QMS records like change controls, deviations, etc. as an when required to management through Quality metrics, data gathering, etc and to conduct the meeting for its progress and timely closure.
• Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP
• Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures.
• Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/ transactions in SAP System
• Perform the product change over clearance activity in manufacturing, packing/repacking area.
• To operate various software such as Trackwise, SAP, LIMS, BRMS, EDAMS, EDMS etc.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc. (Organic Chemistry / Analytical Chemistry)

Experience

Tenure:  7 to 9 yrs experience in API manufacturing Units in Quality dept

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).