Title:  Senior Officer

Job Title:

G12B

Business Unit:

Global Quality and Compliance

Job Grade

Senior Officer

Location:

Ranipool

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:

To monitor all activity in QC department as per GLP.

To ensure the proper closing of OOS, Lab incident, OOC & OOT, Batch rejection (RM, PM, FP & Stability) on time.

To review OOS, Lab incident, OOC, OOT, Non conformities and to ensure that the current procedure is being followed by the QC to identify the root cause and establishment of CAPA is in line with the standard operating procedure.

To review the Log books/Formats, Electronic & paper based raw data generated in QC Lab as a secondary check by QA of QC.

To prepare, review of trend of all laboratory errors & effective CAPA implementation to reduce laboratory errors.

To monitor completion of Analyst qualification prior to assign work to analyst.

Periodic review of Data Integrity and Shop floor inspection of Lab as per predefined procedure.

To review the Reduce Testing protocol as per SOP.

To Review message centre audit trial in daily basis.

To Review CSV documents as process quality Lead.

To review LIMS audit trial for pending sample on monthly basis.

To keep NDPS Raw material samples in control area and periodic quantification of Raw material NDPS samples.

Preparation of Monthly data for laboratory error for CQA Reporting.

To review the change control of QC and ensure its closer and implementation verification.

Preparation of Monthly report in Quality matrix applications.

Execute assigned activities within established timeframe

To initiate change control for SOP revision as per Site requirement or GSOPs requirement and prepare the SOP as per requirement of Analytical QA.

Completion of individual training requirements within timeline.

To ensure the audit compliance.

To review all quality events and ensure its closer and implementation verification.

Ensure GxP compliance at site.

Ensure adequate Risk Assessment is performed for critical activities.

Ensure continuous improvement of quality systems as per Good Manufacturing Practices requirements.

Review/Support to draft response of internal/external audit observations for computerized systems and ensure its compliance.

Any other work assigned by QA Head, Quality Head or Senior Management.

Travel Estimate

Job Requirements

Educational Qualification

B.Pharm

Experience

Tenure:  4 to 7 Yrs

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).