C&q Lead

1 week ago

Central Singapore Emprego SG Full time

**Location**

Singapore, Central Singapore

**Job Type**

Contract

**Salary**

$5,500 - $8,000 Per Month

**Date Posted**

1 minute ago

Additional Details

**Job ID**

15938

**Job Views**

1

**Job Description**:
Roles & Responsibilities

**Responsibilities**:

- Routine coordination meeting with Manufacturing and Process Engineering to resolve any issues/day to day SAT activities
- Align with Manufacturing and Process Engineering and submit the execution plan
- Routine coordination for Raising & Closing of discrepancy due to red line, deviations, project change control etc
- Routine coordination - Post review and approval of SAT documents as per site requirement
- Support to SAT summary generation
- Support to Archival of SAT document as per site requirement
- Coordinates and Supervises all C&Q activities related to the project, managing the project C&Q resources
- Liaise with the various stakeholders on the Project C&Q team and the overall project
- Approves C&Q planning documents detailing overall strategy for the project
- Develops and approves the master list of C&Q test documents and activities
- Reviews and Approves C&Q summary reports
- Ensures the C&Q schedule is developed and maintained
- Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned
- Pre-approval and Post-approval of C&Q test documents
- Manages daily C&Q coordination meetings
- Responsible for Overall Tracking and Reporting of C&Q status and risk/issues
- Ensures Startup of equipment/utilities is completed in a safe and coordinated manner
- Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
- Participation in C&Q activities
- Review and input into technical requirement specifications and vendor turnover documentation
- Review and/or author C&Q deliverables e.g. System classification, System Boundary Drawings, Requirement Traceability Matrix
- Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & documentation

**Requirements**:

- Degree in Science or Engineering or equivalent
- At least 5 years of related working experience in Pharmaceutical / Biotechnology GMP environment
- Good communication skills
- Able to work autonomously as well as in a team
- **
Must be comfortable with Contract basis role**

Tags

cq

lead

biotech

pharma

contract

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