Job Details

ID #45987982
State Massachusetts
City Devens
Job type Contract
Salary USD TBD TBD
Source TSR Consulting Services, Inc.
Showed 2022-09-25
Date 2022-09-24
Deadline 2022-11-22
Category Et cetera
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Commissioning/Qualification Specialist / Specific Commissioning and Validation support

Massachusetts, Devens, 01434 Devens USA

Vacancy expired!

Our client, a leading pharmaceutical company, is hiring a Commissioning/Qualification/Specific Commissioning and Validation Support on a contract basis.

Work Location Devens, MA/Hybrid

Summary
- Participate as part of a cross functional global project to qualify QC instruments and associated software - Create, execute, and review network-led QC instrument/software qualification documents in support of global QC projects - Support the implementation of a standardized global qualification for QC instrumentation and associated software across multiple client QC sites - Author qualification related deviations, identifying root causes and robust CAPAs - Author qualification related change controls and validation plans - Update client procedures and documents to implement data integrity controls arising from instrument qualification programs. - Serve as liaison with lab-IT teams to harmonize 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. - Support general QC asset management - Coordinate/interface with vendors for servicing/maintenance/upgrades - Execute periodic assessments/decommissioning as needed

Qualifications and Experience Required:

- Bachelors degree in relevant scientific or computer area with 7 - 10 years experience in the biopharmaceutical industry or MS degree with 6+ years experience or equivalent combination of education and experience. - Minimum 6 years experience in a role either (a) QC instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software - Demonstrated expertise in large projects, prioritizing workload with minimal supervision - Demonstrated ability to work independently as well as contribute to a team based collaborative environment - 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 travel when required

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