PPD Senior Analytical Instrument Qualification/CSV in Devens, Massachusetts
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
Responsibilities will include (but not limited to):
- Deliver qualification/validation documentation s) as part of a cross functional global project team to upgrade QC instruments and their associated software to operate with Windows 10 PCs and ensure timely release for use in QC. Examples of documents include URS, DQ, CSV testing, DI assessment Summary Reports.
- Design and implement validation strategies for QC analytical instrument software upgrades to operate with Windows 10, across The Client's QC Laboratories.
- Author, review and/or approve network led QC instrument software validation documents and associated testing
- Lead qualification related deviations/software defects, identifying root causes and robust CAPAs.
- Serve as liaison with Lab-IT teams to standardize QC instrument’s software configurations for Windows 10 use
- Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument computer system validation and Data Integrity requirements.
- Report on qualification status, project timelines, and escalate challenges as appropriate to Network QC Management
- Organize and manage cross functional team meetings to deliver assigned instrument software upgrade re-qualification projects.
Education and Experience:
- BS Chemistry or scientific discipline and 7 years of related experience
- OR Technical certification and 10 years of related experience
- Vendor tool certifications a plus
- Or equivalent education and on the job training/experience
Knowledge, Skills and Abilities:
- Must be capable of independent workload management with minimal supervision.
- Minimum of 7 years’ experience in the pharmaceutical industry with minimum of 5 years’ experience of qualification projects either for analytical Instrument hardware qualification or Computer System Validation (CSV).
- Detailed knowledge of regulatory requirements (21CFR part 11, EU annex 11 and GAMP) related to QC instruments and associated software validation.
- Demonstrated experience (>2 years) in leading qualification activities across multiple teams, with proven track record of on-time delivery.
/PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and
balanced environment where they can thrive. Below is listed the working environment/requirements for this role:/
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Organization: *US BU
Title: *Senior Analytical Instrument Qualification/CSV *
Location: MA-Devens-FSP Devens MA
Requisition ID: 188445
Other Locations: US-NJ-Princeton-FSP Lawrenceville NJ
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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