IT CSV Analyst
1 week ago
Key Responsibilities:
- Deliver measurable business results to global health and life sciences clients through consulting engagements.
- Act as a team member, track lead, or engagement lead on client projects, ensuring successful delivery of objectives.
- Conduct thorough problem analysis and structure complex business solutions tailored to client needs.
- Perform gap analyses and recommend improvement opportunities by collaborating with cross-functional client teams.
- Review, approve, and acknowledge validation deliverables, ensuring alignment with compliance standards.
- Execute consulting engagements in a global delivery model, partnering with teams across regions.
- Contribute to organisational growth by participating in internal initiatives and firm-building activities.
Qualifications and Skills:
Experience:
- 4–10 years of professional experience in the Life Sciences industry, preferably within a consulting organization.
- Proven ability to manage multiple projects and adapt to changing priorities in complex environments.
Regulatory Knowledge:
- Strong understanding of pharmaceutical compliance regulations such as 21 CFR Part 11, GxP, and GAMP 5.
- Knowledge of risk management processes and compliance concepts (e.g., Change Control, Deviation, Supplier Management).
Technical Skills:
- Familiarity with validation tools like HP ALM or ValGenesis.
- Understanding of SaaS/Cloud qualifications and Agile/Waterfall methodologies.
- IT background to address program complexities is preferred.
Soft Skills:
- Exceptional communication and stakeholder management abilities.
- Collaborative and adaptable attitude, with a focus on teamwork and results.
Location: Multiple locations
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