Overview
On Site
Full Time
Skills
Quality Assurance
Acceptance Testing
Functional Requirements
Documentation
IQ
OQ
PQ
Policies and Procedures
Science
Good Manufacturing Practice
Manufacturing
Computerized System Validation
Microsoft Office
Document Management
Veeva
Communication
Technical Writing
GMP
Job Details
Responsibilities:
- Provide Quality Assurance oversight for the execution, commissioning, qualification, and validation activities for major projects.
- This may include, but is not limited to; Factory Acceptance Testing, construction oversight, execution of onsite commissioning and qualification activities, support for process validation, etc.
- Ensure execution of capital projects consider USDA and EMA regulatory and quality requirements.
- Review relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, validation plans / protocols, etc.
- Escalate protocol departures of critical nature and ensure issues are addressed and remediated accordingly
- Provide technical consultation and interpretation local procedures, corporate standards and regulatory expectations.
- Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and policies and procedures. Exemplify "Safety First and Quality Always" mind-set.
- Bachelors of Science degree in Engineering or related fields
- 3+ years supporting cGMP manufacturing?
- Prior experience in C&Q, CQV and/or CSV
- Proficient with computer systems including Microsoft office and electronic document management systems (Veeva)
- bility to organize and prioritize multiple tasks and to problem solve effectively
- bility to work under time pressure and exert good judgement in special situations
- Strong communication and interpersonal skills
- Excellent technical writing skills.
- Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.
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