QC INSTRUMENT AND SOFTWARE VALIDATIONRequired Skills:
- 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 prioritize 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.
- Candidate is expected to display the Client's Behaviors, which enable them to be successful and perform at their highest level:
- Passion: We pursue excellence to help patients prevail.
- Innovation: We embrace new ideas.
- Accountability: We own our outcomes and the outcomes of others.
- Speed: We act with urgency and agility.
- 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 Client's QC sites.
- Implement validation strategies for QC instrumentation and associated software, across the Client's 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 the Client's procedures and documents to implement data integrity controls arising from instrument qualification programs.
- Serve as liaison with lab-IT teams to harmonize QC instrument's 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
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jim: email@example.com
ALPHA'S REQUIREMENT #20-01775
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE