Responsible for the audit, pre-approval and post-approval of all process validations protocols, cleaning protocols and analytical test method protocol as the QA signature.
Maintain and control the Validation Change Control Program for the validated/qualified systems and the Validation Management System (VMS).
Review and approval of Validation Master Plan.
Create validation documents, such as Soltraqs Change Plans, Validation Plans, Technical Reports and Position Papers.
SME on process validation aspects (process changes, cleaning validation, dust controls, hold times, test method validation, analytical instrumentation qualification).
Conduct training related to Validation, Qualification and Management of change.
Responsible for continuous improvement aspect of process validation by developing and supporting projects to streamline process from unnecessary tasks and paperwork.
Provide leadership and guidance for validation related CAPA activities.
Member of the Quality Risk Management and participate in development of FMEAs and Risk Control Plans as validation SME.
Administer the Validation Review Board.
Bachelor Degree in Sciences (Chemistry, Biology, Microbiology, Engineering or other technical/scientific area is required.
Eight (8) years minimum of experience in quality assurance or related field handling validated/qualified systems on a regulated industry.
Previous experience in Q uality Risk Assessment, Change Management and Cleaning Validation is highly desired.
Previous L eadership experience, managing direct reports.
High degree of initiative, decision-making, and responsibility which would enable
the candidate to perform efficiently with a minimum of supervision.
Exposure to FDA/DEA regulations and inspection.
Excellent interpersonal relationships with direct reports, peers, and supervisors
Must be fluent in Spanish and English, both verbal and written.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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Dental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
Provide Quality oversight and approval regarding qualification and validation in compliance with regulatory regulations/guidelines. Administer and control the Validation program which includes equipment, processes, utilities, facilities, computers, cleaning procedures, laboratory equipment, and analytical methods to demonstrate that product will perform consistently as intended.
Abbvie · Barceloneta, Barceloneta, PR