Senior Quality Engineer

1 day ago

Singapore PM ASIA PROJECT SERVICES PTE. LTD. Full time

**Responsibilities**
- Lead the engineering and execution Quality lifecycle
- Maintain Site Quality Master plan. Responsibilities include oversight for the development, completion, logging and archiving of documentation on protocols, Quality Master Plans, and quality Summary Packages
- Generates the quality schedule, drives execution of workload and monitors performance to plan and tracks status of quality activities and documentation
- Approves quality protocols prior to execution of work, ensuring content is accurate and in a timely manner to meet schedule requirements
- Drive compliance of the sub
- contractor’s quality plans
- Oversee the development and lead the closure of key validation packages / stages. (DQ, IQ, OQ, PQ)
- Ensure validation packages are following Quality plan and standards
- Establish and maintain system lifecycle documentation (e.g. Validation
- Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final reports
- Evaluates data from executed validation protocols and ensures summary reports are generated and approved, Ensuring quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables
- Establish quality compliance checklists, FAT checklists and others as required.
- Develop and present project status updates to relevant stakeholders
- Support development and tracking of project related training requirements
- Support HAZOP’s, documentation squad checks, risk assessments, design reviews, workshops and other project related activities.
- Manage closeout of corrective actions associated with validation activities
- Develop project summary reports
- Generates or approves Quality Risk Assessment documents in relation to executed quality activities
- Ensure that the Change Control Procedure is implemented and maintained throughout the project lifecycle
- Manage the documentation handover packages

**Requirements**:

- Bachelor’s degree in science or engineering and a minimum of 10 years of validation experience in the data center or pharmaceutical industry
- Hands on quality experience with manufacturing equipment including tanks, Homogenizers, Pumps, sterilizers, parts washer, HVAC, controlled environmental chambers and utilities
- Demonstrated proficiency and knowledge of CGMPs, industry validation practices, and change
- control practices
- Demonstrated ability to effectively write technical documents, including test plans, protocols,
- and reports
- Excellent people management skills including collaboration and influencing with key stakeholders
- Strong change management skills, experience of driving initiatives relating to cultural change

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