QMS- Officer/Sr officer

2 - 7 years

1 - 4 Lacs

Posted:1 day ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

QMS Related Activity: -

1. Handling of market complaint investigation, documentation and follow-up and reports closure

2. Handling of CAPA & change control activity.

3. Issuance, control and retrieval or batch records, SOPs, Logbook, and other documents.

4. Prepare and review Annual product quality review.

5. Management of control sample room.

6. Preparation and review of SOP.

IPQA Related Activity: -

7. To take shop floor round and do gap analysis between practices followed vs GMP practices.

8.. To review all executed BMR, BPR and Final Batch Release of Finished Product in SAP for Sale or Distribution.

9.To perform line clearance and In-process checks in manufacturing and packing operations.

10. Withdrawn of samples in process/finished product/stability samples/control samples and any protocol related samples.

11. To ensure data assurance and reliability at site as per ALCOA+ principle.

12. Review of master batch manufacturing record/Batch packing record.

1 3. To perform the validation batches activity during manufacturing and packing operation. 1

4. Review and approval of area and equipment qualifications/requalification protocol and report.

15. Working with Track n Trace, Trace link like software's for sampling, product verification.

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