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validation strategy for a given sector of validation... and corporate validation requirements and policies. Also responsible for ensuring validation practices are......
validation strategy for a given sector of validation... and corporate validation requirements and policies. Also responsible for ensuring validation practices are......
For your reference, we have included the original job posting below.
Validation Section Manager
Job Number:
43889215
Company Name:
Hospira
Job Location:
McPherson, KS US
Job Categories:
Healthcare & Medical Engineering & Architecture
Minimum Education:
4-Year College Degree
Validation Section Manager
Hospira currently has an opening for a Validation Section Manager at our McPherson, KS location. The individual in this position will work in the Quality Assurance organization as part of the Validation Group and manage a team of 1-5 direct reports. This person is responsible for the establishment and execution of the validation strategy for a given sector of validation (i.e. equipment, processes, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies.
Job Responsibilities:
Ensures validation practices are compliant with all of the most current applicable regulatory requirements and are current with industry standard
Responsible for prioritizing, tracking, and reporting of major validation initiatives, including resources (both physical and personnel) and capital validation budget
Implements the qualification program, develops qualification procedures for equipment, processes and control systems
Assumes the supervisory responsibilities of reporting exempts and non-exempts
Serves as a primary liaison between Validation and Manufacturing, Engineering and the Laboratories on projects/programs requiring design control and validation.
Guides and influences new product teams through design, validation, and interfaces to regulatory compliance and assures robust product vs. customer/product requirements.
Requirements:
Job Requirements:
Bachelors’ Degree in Engineering or Science
Candidates with other technical Bachelor’s degrees will be considered if they have five (5) or more years of direct validation experience
Minimum of seven (7) years experience with a pharmaceutical GMP environment in one or more of the following disciplines: Validation, Process/Product Engineering or Quality Assurance
Must have a minimum of five (5) years of direct validation experience
Thorough knowledge and understanding of cGMPs, FDA and EU regulations and current pharmaceutical industry standards
Must have extensive experience talking/dealing with regulatory and third party representatives. Must have good organizational, presentation, meeting facilitation, project/time management and technical writing skills.
A minimum of three (3) years of supervisory experience is required with supervision of exempts being preferred.
In place of the three-year supervisory experience, experience in project management/leadership may be considered.
