•Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performed.
•Review all related protocols, define the validation approach, the required qualifications, the sampling plan, and ensure the follow-up and tracking of the validation's activities of the group.
•Assure the monitoring and reporting programs to maintain the accurate validation state of process/systems by reviewing and approving the Facility Validation Master Plan (FVMP).
•Provide validation expertise and support for the development (or modification phases) of manufacturing facility, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
•Review in a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
•Participate in the risk assessment related to the project.
•Review URS, FS, and DS for quality validation requirements.
•Review FAT, IQ, OQ, & PQ protocols and reports in a quality validation perspective.
•Assure requirements traceability throughout the whole project validation file (from URS to PQ).
•Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable, and consistent operation of the system.
•Evaluate, analyze, and approve deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon pertaining to validation protocols.
•Take part in internal/external audits.
•Provide the required information to support the preparation of facility & process related files for the various regulatory agencies.
•Attend cross-functional planning meetings to ensure consistent validation approach.
•Create and prepare training plans, deliver training and qualification to employees.
•Coach and mentor employees in order to improve team performance and individual development.
•May perform other duties as assigned. Qualifications
•Strong interpersonal skills and great attention to detail are necessary.
•Must be a strong team player with good problem solving, and good verbal and written communication skills.
•Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Positive Be Accountable Be Results Oriented
Education and/or Experience
- Be An Excellent Manager of Self and Others
Minimum of a BA or BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience - e.g. education or employment in sciences or validations) having a minimum of 5+ years related experience or 4+ years related experience w/ an advanced degree. Working Environment
•Normal office environment.
•This position requires shift, weekend and holiday work.
•May be required to travel for business reasons, e.g. training and meetings.
•Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
•May require immunization before performing work within the manufacturing area.
•May be required to work or be assigned to a different shift as needed.
•Must be able to work more than 8 hours a day or 40 hours a workweek as required.
•Overtime may be required at times.
•Will have interaction with other people.
•Pace may be fast and job completion demands may be high. Physical Demand
•The overall physical exertion of this position is sedentary.
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.