Quality & Compliance Engineer (Pharmaceutical Manufacturing)
1 week ago
Responsibilities
- Lead audit readiness program and maintains regulatory requirements for Facilities and Engineering department
- Interface regularly with Quality Assurance, Manufacturing and other departments to facilitate decisions pertaining to quality system deliverables
- Responsible for specifying and coordinating training, development, and compliance for Engineering Compliance personnel
- Work closely with Quality and Regulatory groups for the Facilities and Engineering departments to address potential compliance issues
- Provide primary support for all regulatory and partner audits and inspections
- Develop, track, and maintain Facilities and Engineering department metrics for presentation to site leadership.
Requirements
- Bachelor’s Degree in Science or Engineering and a minimum of 3 years of quality and compliance experience in the pharmaceutical manufacturing industry
- Demonstrated proficiency and knowledge of CGMPs, industry validation practices, and change control practices
- Demonstrated ability to effectively write technical documents, including test plans, protocols, and reports
Tell employers what skills you have
Pharmaceutical Industry
Training Development
Quality Control
Archiving
Risk Assessment
Quality Management
Quality Assurance
GMP
Compliance
Quality Engineering
Audits
Change Control
Regulatory Requirements
Pumps
Life Sciences
Process Control
Manufacturing
Audit
Commissioning
Mechanical Engineering
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