IT CSV Consultant
6 days 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:
6-10 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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