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.”
JOB DESCRIPTION:
Responsible for Quality operations which includes Bulk Manufacturing, Quality Control, Engineering , IT & Warehouse areas compliance and handling of QMS elements pertinent to entire Bulk manufacturing, QC, IT & Warehouse. Quality interface to external agencies like CDSCO, NIB and any other third party / national & international agencies through internal regulatory.
Essential Job Functions:
Review & Approval of SOPs pertinent to Bulk manufacturing, Engineering, Warehouse, Quality Control, IT and other general areas.
Review & Approval of URS, DQ, IQ, OQ & PQ protocols pertinent to Bulk manufacturing, Engineering, Warehouse, Quality Control and other general areas and ensure that further periodic re-qualifications of Area / Equipments are carried out based on schedules.
Handling of Deviations, Change Controls & CAPAs pertinent to Bulk Manufacturing areas, Quality Control, Engineering, Warehouse and Housekeeping areas. Any other associated reports pertinent to GMP areas.
To ensure the receipt, issue & control of Raw material handling in the site as per applicable Sun Pharma control strategies.
To ensure GMP compliance to approved procedures / practices as per SOP, escalate the issues w.r.t GMP, report any serious issues observed as per company policies and procedures.
Control and reconciliation of Research, Master / Working Cell Banks and maintenance of relevant documentation.
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Review of specifications and testing protocols of material / product pertinent new / existing product and new introductions if any. Any method transfers or Validation protocols / reports.
Review / verification of executed BMRs and batch release checklists till Drug substance stage.
Review of Study protocols like PV/CV/Change over, oversight of study execution, compilation of data, review & approval of reports.
To ensure completion of Transport Validation activities, Thermal cycle study and Bio-burden Validation activity for each product as per SOP and Validation Master Plan.
To handle Failure investigation of Unplanned Deviations / Out of Specifications (OOS) / Out of Trends (OOT) and approve the same by ensuring the appropriate actions are in place.
Periodic review of Water & EMP trends, investigations and to ensure actions proposed are implemented.
During Internal & External audits, GMP compliance, minimization of observations and further compliance verification.
Continuously upgrade skills of self and subordinates through training to ensure the jobs are performed effectively.
To review, coordinate, monitor and ensure the closures with the cross functions at the site regarding audit schedules, audit findings, corrective actions, trainings and audit compliance reports.
To review and approve the Self-inspections (internal Audits) plan, ensure that scheduled audits are performed for calendar year, reports and compliance of for all the cross functional GxP, associated departments.
To ensure compliance to Retention/control sample management and document cell management in line with SOP for retention, destruction and withdrawals.
To ensure updation of control limits for Out of Trend results for Drug Substance / Intermediate (if any) based on SOP and Annual Product Quality Review comments. QMS trending and escalation matrices to the top management through notifications / review meetings.
To respond to the marketing & Production Planning queries and provide data to Regulatory department for regulatory filing and annual amendments. The release check list is concurrently updated as per regulatory and customer commitments through concern corporate Quality teams.
To ensure that Stability schedules, Stability/Holding time study Protocols and initiation of modification or discontinuation of stability/Holding time study protocols for intermediates as per SOP.
To ensure that applicable GQS/GSOPs implementation and tracking at site.
To review and ensure all the Computer System Validation / Process Control Systems against applicable GSOPs / site SOPs, activities as per site and Corporate Quality requirements and escalate any issues and resolve the same.
To review / approve the systems inventory, user access of all the computer systems at site and handle the Process Quality Lead / Site QA-IT/Head role for all Lab systems and Process Control systems respectively.
Management Review:
To co-ordinate and attend the meeting at Plant level with cross functional heads during periodic review boards and other ad-hoc production planning / support from Quality.
To attend management review meetings, action items tracking and compliance to meet the market demands for continuous supplies.
To ensure the Quality Metrics data related to scoring / monitoring as per the defined template by Corporate governing team through QMA application on monthly basis and ultimately maintain the site Quality Index at a set target, consistency for QMS compliance / product Quality.
To ensure continuing suitability and effectiveness of pharmaceutical quality system through management reviews/Policies/Procedures.
Any other work assigned by Cluster Head, to ensure Quality Head signatory as designee of site Quality.
Education: M.Sc. Biotechnology/ Biochemistry
Experience: 10-12+ years’ experience in QA
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).
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