Company Profile:

Our client is subsidiary of US MNC involved in manufacturing of API / Excipients. The company focuses on continuously reviewing opportunities in the pharmaceutical industry as well as other growing segments to offer new and innovative products.

Position: QA Executive / QMS Document Controller

Job Location: Naroda (Ahmedabad)

Job Description :

Responsibility of QC related works :

Analysis & reporting of RM / FP / In-Process sample by instrumental method

Responsibility of out side laboratory analysis and maintain records

Analysis on Instruments

Promotional sample & documents & tracking records

Handling and responsibility of QMS Documents :

Change Control,

Deviation,

Out of Specification,

Market Complaint,

Corrective and Preventive Action (CAPA)

Document Controls :

All document Issuance & Retrieval

COA preparation

BMR & BPR – Preparation & Review

Specification, Method of Analysis & Protocol & Report preparation for Finished product, Intermediate product, In-process, Raw material, Packing material.

Standard Operating Procedure (SOP) Preparation

Customer Query Related work/investigation.

Policies & system procedures preparation.

Training Calendar preparation and control.

Qualification / Calibration / Validation :

Responsible for all Calibration activity Internal & External and maintained the record.

Responsible for Equipment Qualification & Documentation control

Vendor Qualification and regular follow up for updated documentation by the supplier.

Desired Profile :

M.Sc-Chemistry / B.Pharm / M.Pharm with around 8 yrs. experience in Documentation related to QMS Documentation, Vendor Qualification & Validation process in any API / Excipients Manufacturing Plant.