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Job Reference Number


Client ID:


Posted On:

Feb 16 2012



Job Type:




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
improvement requirements

• 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
influencing skills