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Senior Quality Engineer Jobs
Company | West Pharmaceutical Services |
Address | Scottsdale, AZ, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing,Packaging and Containers Manufacturing,Pharmaceutical Manufacturing |
Expires | 2023-10-10 |
Posted at | 9 months ago |
Description
- Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation
- Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.)
- Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions
- Responsible for compliance to West’s validation program
- Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling
- Ensure compliance with Quality, Business Continuity, Safety and Environmental standards and applicable regulations
- Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items
- Provide required training to support qualification activities
- Understanding and facilitation of Risk documentation to ensure compliance with ISO 14971 and ISO 31000
- Support Engineering and Operations groups during the process development and Validation phases of customer products’ life cycles
- Other duties as assigned
- Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, associated regulatory bodies and West functional groups
- Graduate degree (MS) preferred
- 6 - 10 Years of experience
- Bachelor’s degree or equivalent experience in a technical discipline including Biology/Microbiology, Chemistry or Engineering
- Knowledge of validation of automated assembly, software, and manufacturing processes
- Knowledge of ANSI/ISO standards
- Minimum of two (2) years’ experience writing, executing and summarizing protocols
- Knowledge of FDA, cGMP, ISO and Clean Room standards
- Good problem-solving skills and be able to function independently or as a member of a team
- Excellent written and verbal communication skills
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