KEY COMPETENCIES

• Project Management: Anticipate and address issues proactively, planning resolutions within established timelines.
• Effective Communication: Provide clear and concise correspondence with clients and team members.
• Technical Writing: Produce detailed and accurate project plans, risk assessments, protocols, and reports with minimal revisions.
• Document Management: Oversee the complete document lifecycle from creation and review to archival.
• Stakeholder Engagement: Regularly engage with stakeholders to ensure alignment on project deliverables.
• Problem Solving: Apply systems thinking to manage unforeseen circumstances effectively.
• Analytical Thinking: Review, analyze, interpret, and summarize system and process data.

ESSENTIAL QUALIFICATIONS

• General Experience: Over 3 years in a pharmaceutical or GMP environment, with expertise in one or more of the following:
  1)Quality Systems and Operation
  2)Quality Control
  3)Manufacturing
  4)Engineering

5)Technology Transfer

• Commissioning, qualification and validation (CQV) Experience: Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, IQ/OQ/PQ Protocols, etc) in CQV disciplines such as CIP, SIP, process, utility, process equipment, automation, computer system, lab system.
• Education: Minimally a Bachelor’s degree in Engineering or Science, or a related technical discipline, or equivalent relevant experience.
• Regulatory Knowledge: Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4, and other regulatory requirements.

Valuable Experience

• Deviation Handling: Experience with root cause analysis and CAPA management.
• Advanved Technical Knowledge: Possess advanced technical knowledge in more than 1 CQV discipline.
• Quality Control: Experience with aseptic techniques, LIMS qualification, MES troubleshooting, and test methods validation (sterility tests, disinfectant tests, etc.).

Job Types: Full-time, Permanent
Pay: Up to $7,500.00 per month

Benefits:

• Dental insurance
• Health insurance

Schedule:

• Monday to Friday
• Shift system

Education:

• Bachelor’s or equivalent (Required)

Experience:

• CSV: 5 years (Required)
• DeltaV: 5 years (Required)

License/Certification:

• Permanent Residency (PR) (Required)

Location:

• Tuas (West Singapore) (Required)

Work Location: In perso

Please refer the Job description for details