QC Instrument and Software Validation Specialist

Location
Devens, Massachusetts
Posted
Nov 03, 2020
Required Education
Bachelors Degree
Position Type
Consultant

TSR is a premier national U.S. staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical Company, is hiring an QC Instrument Validation Specialist.

Participate as part of a cross functional global project to qualify QC instruments and associated software.
Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five *** QC sites.
Implement validation strategies for QC instrumentation and associated software, across *** QC Laboratories.
Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as;
Network QC Instrumentation Standardization and Windows 10 upgrades.
Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
Author qualification related deviations, identifying root causes and robust CAPAs.
Author qualification related change controls and validation plans.
Update *** procedures and documents to implement data integrity controls arising from instrument qualification programmes.
Serve as liaison with lab-IT teams to harmonise QC instruments software configurations where applicable
Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
Provide updates on qualification status, project timelines, and escalate challenges as required.
Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team

Qualifications and Experience required:
Minimum of 2 years experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role.
Demonstrated expertise in large projects within a complex high performance team,
Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects.
Self-directed with a high degree of professional integrity, organization, and attention to detail.
Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Ability to work across timelines and be available to travel when required.
Demonstrated use of flexible thinking and growth mind-set is an advantage.