How Remoteville checks and expires listings
Senior Quality Assurance Engineer Lead
Skills
CapasComputerized System ValidationGxpManufacturing OperationsPharmaceutical ManufacturingProduct RequirementsQuality Assurance
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- B.S. degree and 6+ years of GxP pharmaceutical manufacturing experience
- 2+ years of quality assurance experience
- Knowledge and application of CFR’s and cGMP’s
- Experience with FDA and EU regulations and US/international regulatory agency inspections
- Experience leading internal audits and providing closure reports
- Experience with commissioning, qualification, and validation to meet FDA and other health authority requirements
- Experience with deviations, CAPAs, and Change Controls
- Experience reviewing/authoring standard operating procedures and partner with operations on product investigations
- Experience leading people
- Excellent oral and written communication skills with technical writing experience
- Ability in long-term project planning, team building, budgeting, and operational excellence
Nice to have
- B.S. in Engineering, Chemistry or Biochemistry
- Sterile manufacturing experience preferred
Day to day
- Responsible for design, construction, validation, maintenance, and compliance of facilities, systems, and processes at Carlsbad RLT manufacturing site
- Ensure Quality and Compliance aspects of design and work with Engineering, Manufacturing Operations, and consultants
- Provide strategic quality input on translating commercial product requirements into technical solutions and oversee Computerized System Validation Lifecycle