QA Specialist (12 month fixed term contract)
Alexion Pharmaceuticals, Inc. (part of AstraZeneca)
Key Responsibilities
- Provide quality and cGMP input and oversight for all commercial manufacturing in the BDS facility
- Review and approval of executed batch records
- Review and approval of Master Batch Records
- Review and approval of Master electronic Batch Record recipes
- Review and approval of technical support documentation
- Review and approval of functional area documentation
- Participate in quality risk assessments
- Provide support and expertise for inspection readiness activities
- Provide oversight of quality management system activities
- Provide quality oversight of calibration and preventative maintenance criticality assessments
- Author, review and approve Quality Related Procedures
- Support the Supplier Management Program
- Complete review and releasing raw materials and components
- Develop and report quality metrics
Requirements
Education
Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering)
Experience
Minimum 3 years in pharmaceutical and/or biotech industry
Required Skills
- English fluency written and spoken
- Strong verbal and written communication skills
- Ability to operate efficiently in a complex matrix organization and international environment
- Strong mature leadership and interpersonal influencing skills
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
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