Quality Specialist

Job Title: Quality Specialist - II

Location: Malanpur (Gwalior), MP

Job Details:

Ensure on time dispatch related activity like verification of any deviation/OOS/LIR & other related QMS elements in the batch or in its batch train.

Ensure review of all documentation (i.e. batch records, test results, deviation, LIR, OOS, CAPA, validation, COA, Change Controls, etc.) and perform disposition (release/rejection) of batches.

Ensure review of executed document like batch record, analytical data, etc. and to ensure on time compliance of error/deviations identified (if any).

Monitoring and follow-up of corrective and preventive actions (review, approval, and on time closure of the CAPA) in order to resolve an event.

Review and approval Process/documentation (i.e. Protocol/report) of reviewing effectiveness to determine the effectiveness of a CAPA.

Involving in investigation, Review, and ensuring on time closure of the investigation with resolution including CAPAs along with effectiveness determination.

Responsible for assuring /coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements.

Responsible for preparation of Annual quality review/periodic quality review.

Any task assigned by QA manager.

Skills:

Good understanding of Pharmaceutical Quality System, GMP & GLP

Qualifications

MSc with 3-5 years of experience preferred.