Prepare for and conduct internal and external audits and inspections according to current legislation and Vifor policies.
Quality Management System
• Responsible for development and maintenance of a comprehensive set of GxP PDs
• Responsible for appropriate quality training for all local staff functions
• Responsible for keeping applicable licenses and Quality Agreements up-to-date
• Develop and maintain a comprehensive set of GxP PDs.
• Develop and maintain a quality manual.
• Ensure appropriate quality training for all local staff functions.
• Assess and approve GxP-relevant third parties, in collaboration with HQ QA Dep't and local Medical Director and General Manager.
• Keep Vifor licenses and Quality Agreements up-to-date and compliant with the applicable local territory laws on Medicinal Products, regulations, and guidelines.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:
• A health, life sciences, or medical science degree; or equivalent by experience
• Minimum 5 years of industry experience
• Knowledge of GxP systems & requirements
• Understanding of GxP principles, concepts, practices & standards
• Understanding of risk management
• Communication skills
- Ability to communicate effectively verbally and in writing; basic presentation skills
- Excellent written & spoken English
- Proficient in Good Documentation Practices
- Experience interacting with auditors and inspectors
• Computer skills
- Good Word processing, Power Point Presentation & Excel application skills
• Knowledge of commercialization and business practices
• Ability to learn new computer interface systems
• Conducting audits
As a federal contractor, Vifor Pharma, Inc. is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason, a genuine religious belief, on an individual basis in accordance with applicable legal requirements. All employees must be in compliance with Vifor Pharma, Inc.’s COVID-19 vaccine policy at the commencement of their employment.