For Project Management - Validation and Change Controls Services.
WHAT MAKES YOU A FIT: The Technical Part:- Bachelor's / Master's degree in Engineering, Microbiology, Biotechnology, or a science-related field with at least five (5) years of experience in commissioning and qualification, preferably in Drug Product processing. Understanding of Qualification, Validation Lifecycle, and regulatory requirements
- Spanish and English communications.
- Experience in:
- Experience in Project Management within the Pharmaceutical Industry is required.
- Proficiency with CDOCS, TrackWise, and Kneat systems.
- Experience managing and supporting Change Control programs.
- Strong experience in Validation Plans and Validation activities, including Change Controls.
The Personality Part: - A Project Manager is a multi-tasking, works-well-under-pressure, organized titan of an individual. But you already knew that, right? Add to this a love of the project management methodologies and lifecycle execution, teamwork and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)- Lead and administer the Validation Assessment Forum.
- Serve as the primary point of contact for Validation Assessment requestors and Change Control Owners.
- Maintain forum agenda, decision log, action log, and open item tracker.
- Coordinate and schedule validation assessments based on priorities, change control due dates, resource availability, and business risk.
- Maintain the Validation Assessment Smartsheet as the source tracker for assessment status, ownership, due dates, dependencies, action items, and escalation needs.
- Assist to Change Control Overview Presentations to perform an initial assessment to ensure assessment requests are reviewed with the right Validation and technical stakeholders.
- Support with any additional technical information not presented during the Change Control Overview needed during Validation Assessment generation.
- Compile and prepare Change Control Validation Plans using technical input and assessment conclusions provided by Validation and subject matter experts.
- Maintain routine communication with Change Control Owners, Validation, area stakeholders, and Validation leadership on priorities, risks, dependencies, and progress.
- Identify risks to meeting Validation Team goals and escalate issues that may affect schedule, compliance, quality, or change control closure timelines.
- Develop and maintain performance metrics for Validation Team support of the Change Control process.
