Analytical Instrument Computer System Validation Technical Lead
A global bio-tech company requires a Analytical Instrument CSV Technical lead to join a global team working on sites in the US, Europe and further afield.
Based in the USA 50% homeworking and 50% on site in Massachusetts.
Responsibilities will include (but not limited to):
- Develop CSV testing strategies for qualification of the upgraded QC instrument’s software and associated interfaces.
- Manage the day to day activities associated with upgrading of instruments to operate with Windows10 software, developing plans and schedules for the team to execute in order to meet project deliverables.
- Collaborating with IT business partners to develop software configurations in order to meet regulatory and Data Integrity requirements.
- Provide Technical SME Review and Approval of qualification documents, ensuring compliance with corporate policies, directives and current regulatory requirements for laboratory instruments, including Data Integrity requirements.
- Technical Approval qualification related deviations, ensuring root cause identified and ensuring robust CAPAs Plans defined.
- Report on qualification status, project timelines, and escalate challenges as appropriate to Network QC Management
- Support the Network leadership team in developing & implementing a strategy to standardize QC instruments (make/model/software) and data reporting in order to reduce Data Integrity (DI) risks.
Qualifications and Experience required:
- Must be capable of independent workload management across multiple project teams.
- Minimum of 7 years’ experience in the pharmaceutical industry with minimum of 5 years’ experience within Computer System Validation (CSV). Experience with Analytical Instrument software validation is desirable.
- Expert Knowledge of regulatory requirements (e.g. 21CFR part 11, EU annex 11) data integrity (e.g. GAMP5, MHRA, FDA, WHO, PIC/S)
- Knowledge of GxP industry standards and regulatory guidance related to analytical instrument qualification and data integrity (e.g. USP 1058, GAMP5, MHRA, FDA, WHO, PIC/S)
- Demonstrated experience (>2 years) in leading CSV activities, with proven track record of on-time delivery.
- Experience with data migration concepts is a distinct advantage.
- Must be able to manage schedules and organise meetings across multiple teams/sites. Working knowledge of MS Project, MS teams, Microsoft Word, Power Point and Excel are essential.
- Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
- This is a fantastic chance to join a global team in a great company.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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