Executive - Quality Assurance, Thane Plant

Job Description

Essential Skills: Knowladge about Pharmacopies reading & searching. Gooc hand for preparation of specifications & STP for RM, FP & Intermediates. SAP Knowladge.

Desirable Skills: Exposure to different validation activities, document review activities, SAP exposure.

Role & responsibilities

1. To prepare Specification and Standard test procedure for Finished Product, Bulk or In process Product and Raw materials.

2. To liaison with Regulatory affairs department and QC department for Specification and MOA preparation.

3. To ensure compliance of specification and MOA being used for commercial product analysis with the registered specification.

4. To maintain the documents submitted to Regulatory affairs department for registration purpose.

6. To initiate change control for change in Specification and Standard Test procedure whenever needed.

7. Review of Pharmacopoeial changes and implementation for the same.

8. To check the analytical method validation and method transfer documents received from Pharma R&D Methods and suggest correction if needed.

9. Responsible for updation of SAP master specification for implementation. 10. Review of Analytical method validation & Transfer documents.