Assistant Manager QA

Job Description

JOB RESPONSIBILITIES

ASSISTANT MANAGER – QUALITY ASSURANCE

Purpose of Position: The Profile require the person to manage day to day working of Department and to
guide the team as per requirement. You are required to do compliance of QMS documentation & data control.

Job Responsibility:
1- To monitor document and data control of all controlled documents (Issuance, retrieval, archival
and distribution).
2- To ensure that all master documents are updated periodically.
3- To ensure that APQRs are prepared, reviewed and approved as per approved procedure
4- Responsible for review and approval of all SOPs, protocols and master controlled documents.
5- Responsible for review and documentation related to OOS, Non conformity, Deviation, CAPA,
Change Control, Market Complaint & Product recall,
6- To Prepare Device Master Files, Quality Manual, Site/Plant Master File and Validation Master
Plan.
7- To review and approve all batch manufacturing and analytical records.
8- To ensure effective implementation of all SOPs and documents related to QMS.
9- To review and approved all new/revised artwork as per approved procedure.
10- To ensure Vendor Development and Qualification as per approved procedure (Audit, review of
questionnaire and performance review)
11- To ensure timely release of finished products.
12- Responsible for review & approval of all Calibration and validation documents.
13- Any other task assigned by Reporting Manager/Seniors.
14- Functional Reporting shall be as per Departmental organogram.
The responsibilities may be reviewed/added as per company requirements from time to time.