Prioritize qualification activities in line with the project
schedules and business needs.
• Develop Validation Documentation to support new
process/product introductions and existing business continuity and process
• Execute qualification protocols as required including risk
assessments and regulatory reviews.
• Resolve and assist in the closure of deviations initiated
during qualification execution.
• Complete 21 CFR Part 11 and Annex 11 Assessments -
experience of CFR Part 11 & CSV would be an advantage but not essential.
• Conduct validation activities in compliance with US and EU
regulations, global procedures and EHS requirements.
• Implementation and co-ordination of the change control
process, review change controls for validation impact, promotes timely approval of all supporting
• Generate SOP’s / other documentation as applicable.
• Validation representative at daily project management
meetings, weekly change control and team meetings.
• Work with all departments in ensuring operational
effectiveness and developing product Quality for business continuity and
process / product introductions.
• Identification and root cause analysis of potential bugs.
• Participate in Troubleshooting.
• Manage defects through a defect tracking system.
• Work with the various departments / groups in development
and execution of validation activities associated with new system or System
• Provide input into all project phases i.e. from design
through to the commissioning and qualification execution phases of the project.
• Proven track record in development / execution of
Validation programs in areas of Systems
• Run / Manage complaint investigation and resolution of
Experience & Requirements• A minimum of 3-4 years
testing experience in an Oracle/ Web based environment/ Microsoft SQL, preferably
in the healthcare industry.• Strong knowledge of CSV/GAMP, 21CFR Part 11, Annex
11, Project Life Cycle and cGMP Regulations, • Working knowledge of development
and test life cycles.• Firm sense of accountability, ownership for end-to-end
project lifecycle and sound knowledge of project management. • Good knowledge
of statistical techniques in the use of problem solving / data analysis.•
Outstanding verbal and written communication and presenting skills with the
ability to interact with technical and non-technical groups.• Adaptable and
flexible • Ability to demonstrate standards of leadership - managing complexity
/ Credo values / Innovations / Customer Focus Flexible Team Player Good