Sr Quality Assurance Associate

Updated: May 13, 2024 04:48 PM GMT

Endo

Alathur, Kerala

This role will have a minimum of 5 to 8 years of experience in documentation management. Having the education qualification of post graduation in chemistry.

Documentation control and issuance:

Issuance and Retrieval of Documents to user departments (BMR, BCR, BPR, AR, ROAs, Logbooks, Forms and any other GMP documents).

Issuance of Specification, Method, Analytical report/ Record of Analysis (Intermediate, Finished product, Stability, Holding time study) to the relevant departments.

QMS:

Handling of Events, Change controls, CAPA, Customer complaints, Product Recall, OOS and any other QMS elements.

Timely completion of Assigned QMS elements on or before the due date.

Verification of CAPA Effectiveness wherever required.

Preparation and review of APQR:

Preparation, Review, and approval of Annual product Quality review documents and any other documents as applicable.

Internal Audit and Walk-through Inspections:

Perform Internal Audits as per schedule and ensure timely closure... More Detail