Senior Executive, Quality Management Systems

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 13,000 - 19,000; Full time

Job summary

Sun Pharma is seeking a Senior Executive – QMS in Panoli to uphold global quality standards within the Global Quality And Compliance unit. The role focuses on reviewing audit trails, implementing quality policies, and aligning site SOPs with Global Standards.

Educational background includes MSc/BPharm/MPharm; experience 5–10 years in QA/QMS. The position requires training coordination, regulatory audits, and ready collaboration across departments to ensure readiness for audits.

Qualifications

• M.Sc / B.Pharm / M.Pharm required.

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.
• 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.

Education

M.Sc / B.Pharm / M.Pharm

Job description

Sun Pharma is seeking a Senior Executive – QMS in Panoli to uphold global quality standards within the Global Quality And Compliance unit. The role focuses on reviewing audit trails, implementing quality policies, and aligning site SOPs with Global Standards.

Educational background includes MSc/BPharm/MPharm; experience 5–10 years in QA/QMS. The position requires training coordination, regulatory audits, and ready collaboration across departments to ensure readiness for audits.