This position is responsible for supervision and management of the validation responsibilities at the La Jolla site. This includes planning, staffing, ensuring proper resources and compliance of the overall validation program and systems. Responsibilities also include the reviewing and development of validation procedures to ensure products meet appropriate regulatory validation requirements, company requirements and customers. Serves as information resource for Validation department, contractors, vendors, internal and external customers. Responsible for the maintenance of the Validation Master Plan including coordinating current and future projects.
Responsible for trouble-shooting and working through validation issues as they arise. Validation representative internal/external audits and for change control procedures
Validation Personnel Management: Provide direction and management to validation department and progam as well as other departments regarding validation policies and requirements.
Ensure adequate staffing and resources, delivery on projects, validations and milestones and makes adjustment and required
Ensure proper training of validation staff and validation training throughout the organization.
Valdiation Program Management: Coordinate validation activities, troubleshoot efforts relating to validations, planning, schedules, review/approve system change request, maintain Validation Master Plan.
Write selected studies and protocols for equipment or systems.
Execute selected studies and protocols for equipment or systems.
Keep abreast of current technology by attending professional meetings and seminars and reading technical literature.
Calibrate and set up validation equipment.
Develop, administer and control validation budget and performance requirements.
Assignments as directed by manager
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Directly supervises 1+ employees in the Validation group. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education & Experience Requirements
Education/Experience: (Indicate minimum levels required.)
BS degree in a scientific discipline or equivalent with 5 to 8 years related experience within a minimum of 2 years leadership experience.
Knowledge: (Indicated special knowledge/areas of exel
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Shire - 2 years ago
Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...