Senior Executive G11B - QA

Job Title:

Senior Executive QA -

Business Unit:

Global Quality And Compliance

Job Grade

G11B

Location :

Panoli

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:

• Review of Audit Trail for Chromatographic Non-Chromatographic Systems.
• Ensure implementation of relevant quality policies, standards and procedures for computerized systems.
• To review and identify gaps of Global Quality Standards/Global Standard Operating Procedure with Site SOPs. To implement the Global Quality Standards/Global SOPs at site.
• To prepare the Departmental Annual Training Planner and tracking for the same.
• To work as Departmental Training Co-ordinator for Learning Management System.
• Overall responsible for training activities for QA Department.
• To review the SOPs of all departments before approval.
• Update data in master drive.
• System GAP assessment/GMP Trending/escalation/shop floor round.
• To review QMS (Deviation, Change Control, CAPA, etc.) related to Quality Control/Micro and QA-IT.
• Review and Approve validation deliverables and lifecycle documentation for computerized systems.
• Review and release of analytical documents in LIMS.
• Participation in handling OOS, OOT and Lab event investigation.
• Ensure resolution of identified risks/gaps related to computerized systems in a timely manner.
• Handling of EDMS activity.
• External audit/Internal audit/Regulatory Audit Management.
• Compliance/Response to audit and inspection.
• Regulatory compliances over view.
• Readiness/Preparation of audits.
• Preparation and Review of Site Quality Monthly Report.
• Preparation of Site Master File Quality Manual.
• Other activities instructed from time to time.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

1. |

   P a g e

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!

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