IT Quality

Position summary

Consultant – IT Quality - CSV

IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. We provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc.

Work you will do
Being part of our team, you are responsible for specific aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires hands on experience on Part 11 compliance of computerized systems. The position provides excellent opportunity to:

· Work with the lead to identify regulatory risks and appropriate remediation

· Work in cross-functional project teams for new product development and other validation projects to include reviews, risk analysis and other QA activities in support of systems development and manufacture

· Assist the lead in developing strategies for process improvement which caters to the needs of the quality organization

· Review validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory)

· Execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMPs)

· Review validation lifecycle documentation

· Work with the lead to review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions

· Provide Quality review and assessment of associated change requests related to computer systems

· Provide progress updates of the assigned deliverables and escalate issues to the lead appropriately

· Participate in trainings and workshops for knowledge transfer and competence building

The team
The R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption.

Qualifications and experience
Required:
Bachelor's degree (or equivalent)
3+ years of experience in pharma or medical device industry with a focus on quality and regulatory compliance
Experience in systems validation
Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall)
Clear understanding of principles, procedures and governance of validation activities.
Excellent written and oral communication skills.
Motivation and skills to work in a team-oriented environment and a desire to work in a company that places a high value on cooperation and group achievement