Scope of Function:|
Primarily responsible for ensuring compliance as set forth by regulatory agencies- Overseeing the internal training program and providing QA oversight for product manufacturing campaigns.
Manager, Quality Assurance
1) Lead the development and management of a comprehensive compliance training program.
2) Enhance training courses to raise quality awareness and improve quality culture across all Operating Units.
3) Coordinate and track training to ensure compliance.
4) Evaluate and implement new and innovative training approaches and other technologies that may be used to deliver training.
5) Oversee the product manufacturing campaigns.
6) Perform reviews for executed Batch Production Records of product intermediates and final product.
7) Assist with technical and compliance issues.
8) Develop, write, and revise cGMP documents.
9) Participate in internal compliance audits.
10) Assist the Head of Department with projects.
Education and Skills Required:
Education: BachelorÂs degree in Life Sciences or a related scientific field.
Experience: At least 3-5 years experience as a trainer. Prior experience in a FDA regulated environment such as pharmaceutical or biologics industry is highly desirable.
Skills: Must be detail oriented with demonstrated organizational and coordination skills.
Outstanding written, verbal and problem solving skills.
Proficient in word processing, power point presentation and computer databases.
Quality Assurance, Quality Control, cGMP Manufacturing, Project Management, Clients and Consultants.
Goodwin Biotech - 21 months ago