Posted in Software 30+ days ago.
This job brought to you by eQuest
Location: Helena, Montana
Position Title: Validation Specialist
Working Location: Montana
Employment Status: Full time
Required Experience: 6 years
Required Education: Diploma
Travel Required: 0%
Job Purpose: This job is part of the MSAT validation organization, to allow the team to balance workload more effectively. The job owner is responsible to provide systems, information and KPI’s to continuously manage and verify that our validation systems support the delivery of complaints, uninterrupted and unconstrained supply and enable operations and quality leaders to manage and continuously improve validation execution in their areas. The job owner is responsible for providing support in commissioning and qualification to team members and sites.
• To Benchmark Competition and to capture Best Practices
• To develop or use adequate IT /OE tools to support the processes, validate the tools and coach key users
• To provide systems, information and KPI’s to:
• Continuously manage and verify that our validation systems support the delivery of a compliant, uninterrupted and unconstrained supply
• Enable operations and quality leaders to manage and continuously improve validation execution in their areas
• Ensure traceability of validation filing
• Responsible for developing and maintaining validation standards on track with regulatory and GSK Vaccines Division.
• Responsible for creating the training materials for validation for the division.
• Responsible for helping host collaborative meetings
• Contribute to the correct definition and implementation of Commissioning & Qualification approaches/strategy in compliance with FDA, EMA and International quality standards for major projects as well as the entire strategy for the division.
• Participate to the regulatory vigilance and QMS maintenance for Commissioning & Qualification (compliance to regulations and corporate quality system)
• Ensure respect of project schedule, cost and quality
• Manage assigned standards and associated documentation
• Support sites/MPU on deployment of standards to develop/improve business operability and inspection readiness
• University or vocational degree in engineering/scientific discipline
• 6 years of working experience required in validation or comparable area in the pharmaceutical or consumer health industry.
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.