Bayer is looking to solve the world's toughest challenges in health and hunger, and this role will support and maintain an effective software quality assurance system, specifically providing quality oversight for software used in manufacturing and R&D processes within the quality system.
Requirements
- Basic knowledge of other technical disciplines;
- Proven ability to demonstrate technical writing skills;
- Knowledge of FDA QSR and ISO Quality and process validation standards.
- Computer System Validation experience;
- GAMP experience;
- Direct experience in medical device industry.
Responsibilities
- Provides Quality Assurance oversight for the validation of quality system software, including manufacturing and R&D process software for Radiology, for the Indianola, O’Hara and Saxonburg sites;
- Engages with project teams to ensure compliance with internal and external requirements for validation of quality system software. This includes compliance with requirements for data integrity, CFR Part 820, FDA Guidance for Industry on Process Validation and CFR Part 11;
- Ensures that appropriate, risk-based principles for software validation are utilized;
- Provides Quality Assurance oversight for changes to quality system software;
- Maintains the computerized software list to ensure that it contains the current quality system software validation information;
- Manages the process to monitor compliance for periodic validation and audit trail reviews. Periodically reports on status of recurring reviews;
- Creates and maintains SOPs, work instructions, forms, templates, and performs required gap assessment;
Other
- 6 - 10 Years’ experience in regulated industry;
- Ability to work collaboratively with other departments;
- Strong communication and interpersonal skills;
- Ability to work well in high pressure environment and manage multiple concurrent projects;
- This is a hybrid position 50% onsite presence is required.
