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 person