
Senior Consultant
1 week ago
Key Responsibilities
- Lead and support MSAT-related projects in GMP-regulated environments
- Develop and manage detailed project plans, protocols, and reports
- Identify and resolve issues proactively, ensuring project timelines are met
- Engage with clients and internal teams through effective communication
- Oversee document lifecycle: creation, review, approval, and archival
- Conduct data analysis and risk assessments to support project decisions
- Collaborate with cross-functional stakeholders to ensure alignment on deliverables
- Apply systems thinking to troubleshoot and solve technical or operational issues
Required Qualifications
- Experience: Minimum 3 years in a pharmaceutical or GMP-regulated environment
- Background: Experience in one or more of the following:
- Quality Systems & Operations
- Quality Control
- Manufacturing
- Engineering
- Technology Transfer
Regulatory Knowledge: Familiarity with ICH Q7, Q8, Q9, ISO 14644, ANSI Z1.4, etc.
Job Type: Full-time
Pay: $4, $7,000.00 per month
Benefits:
- Health insurance
Experience:
- GMP- regulated: 5 years (Required)
- CSV (computer system Validation): 5 years (Required)
- DeltaV: 5 years (Required)
Work Location: In person
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