Manager - Quality Assurance Job in Dd Enterprises

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