Manager - Quality Assurance Job in Dd Enterprises
Manager - Quality Assurance
- Pune, Pune Division, Maharashtra
- Not Disclosed
- Full-time
Job Description
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
Your 4 Step Guide to Career Success
