Validation Specialist - Hangzhou, 中国 - Abbott

描述

MAIN PURPOSE OF ROLE

Responsible for creating and implementing the Abbott Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.

MAIN RESPONSIBILITIES

Represent Abbott Division during internal and external audits of validation projects and documentation.

Write validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.

Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion through specialized experience and training.

Evaluate validation results of validation protocol executions employing specialized experience and training.

Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience.

Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls.

Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes.

Track and report validation progress of corporate validation projects through departmental project tracking tools.

Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.

May lead a project team of moderate scope.

Provides guidance to less experienced staff.

Acts as a mentor to lower level individual contributors.

Influence exerted at peer level and occasionally at first levels of management.

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

Exercises authority and judgment within defined limits to determine appropriate action.

Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Education Level

Bachelors Degree (± 16 years)

Masters Degree (± 18 years)

Experience

Minimum 2 years

Experience Details

2-5 years of related work experience with a good understanding of specified functional area.

Working technical knowledge and application of concepts, practices and procedures.

General understanding of business unit/group function.

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

Exercises judgment within defined procedures and practices to determine appropriate action.

Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.