PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
The Validation Quality Manager will own implement the validation program and manage validation documentation. The Validation Quality Manager will serve as a subject matter expert in the area of validation and production and process controls. They will expedite and coordinate a multitude of interrelated project activities within the daily constraints with changing priorities to ensure the successful completion of improvement initiatives.
1. Understand and apply validation production and process control requirements.
2. Assist with the planning, preparation, review and evaluation of validation protocols and processes related to manufacturing and laboratory equipment, test methods, cleaning, and computerized systems
3. Review and make recommendations for validation test protocols that include critical process steps, critical control points or critical process parameters and specify the acceptance criteria.
4. Create and manager Validation Master Plans that include a planned schedule of activities.
5. Review and make recommendations for validation summary reports that include data analysis and evidence that the requirements in the validation protocol have been met.
6. Recognize and evaluate changes, including additions or modifications to a validated process, to determine the need for and the extent of revalidation.
7. Review and make recommendations equipment qualifications, including design, installation, operational, and performance.
8. Deliver various levels of training on validation and production and process controls.
9. Provide consultation to businesses as SME for data integrity, CFR 21 Part 11 application and Computer System Validation
10. Establish statistical sampling methods for validation protocols and production and process control procedures
1. Bachelor's Degree in Science or related field required.
2. Minimum of 5-7 years' experience in Quality, or related field in the healthcare industry.
3. Proven ability to bring projects to a conclusion.
4. Minimum of 5 years' experience with managing or supervising employees
5. Demonstrates understanding of quality assurance in a regulated (FDA, DEA, ISO) environment.
6. Thorough understanding of the Governmental requirements in a sterile processing environment.
7. Computer skills in word processing, spreadsheets and databases required.
8. Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills.
TRAVEL: 10 to 25% Travel required
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