Lead Quality Assurance resource needed to provide quality support for global computer validation projects in the ERP area, such as SAP, under the guidance of the Global Quality Computer Compliance team.
Job duties will include:
- Reviewing and providing input to validation and test strategies
- Verify documentation is in compliance with internal procedures and external regulations
- Participate in review and approval of requirements, test scripts, reports and other SDLC documentation with a focus on quality, and testability
- In addition, the resource may be pulled to support other programs of the following as needed:
- Participate in process changes in the organization
- Participate in audits
- Participate in change management of additional systems
Education/Training/Work Experience:
The position requires a Bachelor’s Degree in Engineering or Sciences with a minimum of 5-8 years experience working in life sciences industry with focus in the area of Quality Assurance.
Experience working with various GxP Enterprise Computerized Systems (on-premise and Cloud based (SaaS) COTS) used in the life sciences industry. Candidate must be well-versed with Software Development Life Cycle (SDLC) methodologies such as Waterfall and V-model. In-depth knowledge of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle process. Extensive experience developing and using risk based approaches for computer systems validation. Experience in managing multiple projects and determined to get job done correctly and on time.
All your information will be kept confidential according to EEO guidelines.
Skills Required
- Bachelor's Degree in Engineering or Sciences
- 5-8 years experience in life sciences industry
- Experience with GxP Enterprise Computerized Systems
- Knowledge of US FDA regulations, ISO standards
- Experience in Software Development Life Cycle (SDLC) methodologies
