Description
Responsibilities:- Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and quality standards.
- Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
- Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
- Responsible for final authorization/approval/release of documentation/equipment/processes
- Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility
- Plans projects and may initiate and develop plans to ensure their timely completion.
EXPERIENCE/SKILLS:
- MINIMUM: 4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
- Good Manufacturing Practices (GMP)
- MINIMUM: BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry.
- University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred.