G11B - Senior executive - Quality Control

Sun Pharmaceutical Industries Ltd; Ankleshwar; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Sun Pharma invites applications for Senior Executive – QMS in Panoli. The role focuses on reviewing audit trails for Chromatographic and Non-Chromatographic Systems and ensuring compliance with Global Quality Standards and SOPs.

You will organize training, coordinate the Learning Management System, and support internal and external audits. The candidate should have MSc/BPharm/MPharm with 5–10 years’ experience in quality systems, readiness for regulatory reviews, and a collaborative approach to

Qualifications

• MSc, B.Pharm or M.Pharm required.
• 5–10 years of relevant experience in QMS or quality systems.
• Knowledge of audit processes and regulatory compliance.

Responsibilities

• Review audit trails for chromatographic and non-chromatographic systems.
• Ensure implementation of quality policies, standards and procedures for computerized systems.
• Review and identify gaps in Global Quality Standards and SOPs; implement at site.
• Prepare and track the Departmental Annual Training Planner.
• Coordinate Learning Management System training for QA.
• Oversee QA Department training activities.
• Review SOPs of all departments before approval.
• Update data in master drive; conduct system GAP assessments and GMP trending.
• Review QMS documents like Deviation, Change Control, CAPA, etc.
• Review and release analytical documents in LIMS; participate in handling OOS/OOT and lab events.
• Ensure timely resolution of risks/gaps related to computerized systems.
• Manage EDMS activities; support internal and regulatory audits and inspections.
• Prepare Site Quality Monthly Report and Site Master File & Quality Manual.

Education

MSc / B.Pharm / M.Pharm

Job description

Job Title

Senior Executive – QMS

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.

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure : 5 to 10 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. Lets 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).