Officer / Sr. Officer-QA

Job Title:

Officer / Sr. Officer QA

Business Unit:

Global Quality Compliance

Job Grade

G12C / G12B

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.

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 or verification to ensure adequacy, completeness and compliance of documents, procedure, practices, etc.
• Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. To report Rejection/Failure observation immediately. Preparation and review of GMP documents related to activities.
• 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 Follow the labelling and seal issuance procedure for materials after release/ rejection of batches. Involved in dispatch activity and customer COA preparation/ to Verify certificate of analysis.
• Equipment, instrument and utilities etc. qualification and re-qualification protocol and report review for manufacturing section.
• To co-ordinate with change control team for the evaluation of change controls to refer for impact assessment and to derive action items. Review and closure of the change controls/action items in track-wise.
• To escalate or highlight problems in QMS documents, investigations, BMR, ECR and another document time to time.
• To involve in training, internal audits, external audits (Regulatory and customer).
• Preparation and review of product quality review (APOR/POR) and stated documents as per schedule, monthly report and as and when required
• Responsible for co-ordination, monitoring, tracking, participating etc in activities assigned for review verification to ensure adequacy, completeness and compliance of documents, procedure,
• To monitor, Tracking, review/closing of deviations, Out of specification, Investigation. Corrective and Preventive actions, Market complain, Change controls, etc to ensure adequacy in quality management system (QMS)
• Participation in various investigation processes (including cross functional investigation) to identify root cause and derive appropriate CAPA, etc. and closing the CAPA action/QMS documents
• Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, esc
• GMP Walk round in manufacturing plants, Quality Control Laboratory, stores, engineering as per schedule.
• Review of annual summary reports for water systems and annual summary reports for environmental monitoring

Travel Estimate

Job Requirements

Educational Qualification

M.Sc. (Organic Chemistry / Analytical Chemistry)

Experience

Tenure : 4 to 7 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).