Senior Consultant

4 days ago

Tuas, Singapore Nityo Infotech Full time

**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 mínimal 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.
- 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

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