Sr. Officer

Sun Pharmaceutical Industries, Inc.; Jammu district; On-site; INR 279,000 - 670,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. invites applications for a QA/document control role in our India facility. You will handle BMR/BPR issuance, maintain records, and support change control activities to ensure compliance with QA standards.

The position requires B.Pharma or M.Sc. qualification, with exposure to Trackwise, EDMS/EDAMS/BRMS and SAP processes. You will collaborate across departments to ensure accurate documentation and timely reporting.

Qualifications

• Educational qualification as stated: B.Pharma or M.Sc.
• Experience in QA documentation and record-keeping is beneficial.
• Strong attention to detail and ability to collaborate across teams.

Responsibilities

• Issuance of BMR/BPR to user departments.
• Issuance of extra pages and formats to user departments.
• Handling and controlling of all documents and records.
• Retrieval of old QA related documents and records.
• Assigning of training numbers for training and other sheets.
• Management of the control sample room.
• Update and maintain the signature logbook.
• Issuance and preparation of Hold time validation reports.
• Issuance, controlling and retrieval of monthly formats and logbooks.
• Preparation of annual product review.
• Monitoring of environment in control sample room and walk-in cold chamber.
• Trackwise, EDMS, EDAMS, BRMS and SAP related activity.
• Initiate Change Control, Unplanned Deviation, CAPA and Temporary Change Control.
• Review of Process Validation Protocol.
• Prepare and data-compile Process Validation Report.
• Qualification of Plant Equipment (protocol prep, review, execution).
• Prepare Vendor Risk Assessments and Approved Vendor List.

Skills

Documentation mindset

Attention to detail

Collaborative spirit

Education

B.Pharma/M.SC.

Tools

Trackwise

EDMS

EDAMS

BRMS

SAP

Job description

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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 will 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:

• Issuance of BMR/BPR
• Issuance of extra pages and formats to user departments.
• Handling and controlling of all documents and records.
• Retrieval of old QA related documents and records.
• Assigning of training no. for training and other sheet to user department.
• Management of control sample room.
• Update and maintain signature logbook.
• Issuance and preparation of Hold time validation report.
• Issuance, controlling and retrieval of monthly formats and logbooks.
• Preparation of annual product review.
• Monitoring of environment in control sample room and walk-in cold chamber.
• Trackwise, EDMS, EDAMS, BRMS and SAP related activity.
• Responsible to initiate Change Control, Unplanned Deviation, CAPA and Temporary Change Control
• Responsible for review of Process validation protocol
• Responsible for preparation and data compilation of Process Validation Report
• Responsible for Qualification of Plant Equipment (Protocol Preparation, Review and Execution
• Responsible for preparation of Vendor Risk Assessment report and Approved Vendor List.

Job Requirements

Educational Qualification

B.Pharma/M.SC.

Experience

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).