Title:  Senior Officer

Job Title:

Sr Officer  - IPQA

Business Unit:

Global Quality And Compliance

Job Grade

G12B

Location :

Gangtok

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 check the material quantity in Material Issue Order as per BMR/BPR.

To check staging of material (e.g. material description/lot No., item code, A.R. No. Mother Containers and Quantity).

To ensure the prevention of contamination, cross contamination and mix up.

To monitor and record online in-process parameters as per specified frequency in BPR.

To ensure compliance of written procedures of BMR/BPR/logbook on shop.

To collect the PQ sample, micro sample, hold time, finished product sample, control sample, stability sample and CT/trial batches sample as per sampling plan and send to QC.

To facilitate the batch release by timely review and closure of observations of BMR/BPR to be ensured.

To verify the on-line rejection.

Review & approval of recipe in SAP.

To perform AQL for release the intermediate and final stage of manufacturing as per SOP & BMR.

To participate in technical training programs for self-development.

To post sample & creation of TRF in SAP for PQ, Finished, control, micro and stability sample.

To give the line clearance as per approved master batch record (BMR/BPR), SOPs and checklists.

 Review and approval of SFG.

To approve, release and closing of batch record in BRMS.

GEMBA w.r.t CAPA verification/effectiveness check of OOS/UPD observed during audit.

To review QC activity as QA reviewer.

To verify the analytical raw data & provide observations to the analyst if any discrepancy observed.

To review, guide and provide inputs in investigation of lab events, OOS, OOC, OOT, PD, UPD.

To Review QC related document (Deviation, CAPA, change control and SOP).

To verify the audit trail of Instrument and Equipment.

To ensure the Trend data for OOS/OOT/Lab event prepared with in specified time.

To ensure relevant activity of Pharmacopoeia Compliance

Any Other task assigned by HOD.

Travel Estimate

Job Requirements

Educational Qualification

B.Pharma

Experience

Tenure:  3 to 5Yrs

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).