Manager - Quality Assurance

Job Information

Title: Manager - Quality Assurance

Job Type: Full time

Company: DD Enterprises

Country: India

Location: Pune

Published: 25/10/2019

Industry: Manufacturing

City: Pune

State/Province: Maharashtra

Zip/Postal Code: 411026

Job Responsibilities

·         Preparation of SOP and approval and revision of SOP/tracking of SOP, record

·         Preparation of URS deviation list, Risk assessment

·         Client Support for site documentation requirements

·         FAT MOM compliance verification project wise

·         Review and response to comments on validation documents from client

·         Dispatch clearance to accounts for supply PO post submission of FAT compliance and client confirmation

·         Arrange Kick off for new project handover for supply PO and share MOM and follow up

·         Training of new join for QA and internal trainings regarding validation/Documentation

·         Review and approval of QA validation documents

·         Preparation of SS tags list for every project, Operational Manual

·         Collection and distribution of all bought out certificates project wise

·         Receiving and distribution of internal approved drawings as per project

Requirements

Technical Skills

·         Good knowledge about documentation related to commissioning and qualification

·         Good awareness of quality management system

·         Good knowledge of cGMP guidelines and scope of their use to our unit

·         Troubleshooting /response to client comments for satisfactory conclusion

·         Review of technical documents for GMP compliance

·         Good at Client interaction during compliance meeting

·         Development of checklist and guidance documents for improvement of documentation

Functional Skills

·         Review of URS/PO/Technical specifications, P&ID, GA, 3D, electrical drawings, FS/FDS

·         Review and approval of BOM and DQ

·         Review and approval FAT IOQ

·         Review of PRE-FAT schedule, PRE-FAT executed drawings and reports

·         Preparation of Pre-fat comment's and sharing internally for closure and follow up for compliance

·         Any FAT NCR generated /details generated date/closed date follow-up for closure

·         MOM compliance  preparation with meeting cross functional teams

·         Follow up of compliance with team, gather evidence

·         Preparation and submission of FAT compliance to client

·         Review and approval  SAT IOQ

·         After  dispatch site support for SAT IOQ

Benefits

·         Salary Best in the Industry

·         Professional work culture with growth opportunities

·         New learning opportunities through various Training and Development programs for continuous growth

·         Young & energetic work environment

·         Good work life balance

·         Fun filled working atmosphere with lot of employee engagement activities