G12B - Sr Officer QA

SUN PHARMA; Panoli; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharma in Panoli seeks a Senior Officer – Quality Assurance to lead QA activities, audits, and regulatory compliance within Global Quality and Compliance. The role emphasizes ensuring computerized system controls, SOP alignment, and training oversight for the QA department.

Educational background required includes M.Sc or B.Pharm/M.Pharm with 4–7 years of experience in pharma QA. The position focuses on quality management, audit readiness, and continuous process improvement.

Qualifications

• Educational qualifications: M.Sc / B.Pharm / M.Pharm.
• Experience: 4–7 years in QA within pharma.

Responsibilities

• Review Audit Trail for Chromatographic & Non-Chromatographic Systems.
• Implement quality policies, standards and procedures for computerized systems.
• Review and align site SOPs with Global Quality Standards.
• Prepare departmental Annual Training Planner and tracking.
• Act as Departmental Training Coordinator for Learning Management System.
• Oversee training activities for QA Department.
• Review SOPs of all departments before approval.
• Handle QMS (Deviation, Change Control, CAPA, etc.).
• Review and approve validation deliverables and lifecycle docs for computerized systems.
• Review and release analytical documents in LIMS.
• Participate in handling OOS/OOT incidents and lab events.
• Manage EDMS activities and audits (External/Internal/Regulatory).
• Prepare Site Quality Monthly Report and Site Master File.

Skills

Quality Assurance

QA Documentation

Regulatory Compliance

GMP Knowledge

Education

M.Sc / B.Pharm / M.Pharm

Tools

LIMS

CAPA

EDMS

Job description

Job Description:

Job Title: Senior Officer – Quality Assurance

Business Unit: Global Quality And Compliance

Job Grade: G12B

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.

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).