QAQC Manager

3 weeks ago


Singapore PM ASIA PROJECT SERVICES PTE. LTD. Full time
Roles & Responsibilities

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 Engineering and a minimum of 15 years of commissioning experience in the data center or pharmaceutical industry
  • 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

Tell employers what skills you have

Pharmaceutical Industry
Quality Control
Archiving
Risk Assessment
Quality Management
Change Management
Quality Assurance
GMP
HVAC
Quality Engineering
Audits
Change Control
Regulatory Requirements
Pumps
Life Sciences
Process Control
Manufacturing
Commissioning
Mechanical Engineering
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