G12C Officer - QC

Sun Pharmaceutical Industries Ltd; Panoli; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Panoli seeks an Officer – Quality Assurance to ensure compliance with global quality standards and regulatory requirements within the Global Quality And Compliance unit.

The candidate will review audit trails, manage SOPs, QA audits, training coordination and data integrity across QC/LIMS, with 4–7 years of relevant experience and qualifications in M.Sc/B.Pharm/M.Pharm.

Qualifications

• M.Sc / B.Pharm / M.Pharm degree required.
• 4 to 7 years of experience in QA, regulatory/audit environment.
• Experience with GMP, quality systems, and computerized systems is preferred.

Responsibilities

• Review of Audit Trail for Chromatographic & Non-Chromatographic Systems.
• Ensure implementation of relevant quality policies, standards and procedures for computerized systems.
• Review and identify gaps of Global Quality Standards/Global Standard Operating Procedure with Site SOPs; implement at site.
• Prepare the Departmental Annual Training Planner and tracking.
• Work as Departmental Training Co-ordinator for Learning Management System.
• Overall responsible for training activities for QA Department.
• Review the SOPs of all departments before approval.
• Update data in master drive.
• System GAP assessment/GMP Trending/escalation/shop floor round.
• 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

Tools

LIMS

Job description

Officer – Quality Assurance

Business Unit:

Global Quality And Compliance

Job Grade

G12C

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: 4 to 7 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. 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).