IT Computerized Software Validation Consultant

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.