Quality Engineer Specialist
Posted on :
31-07-2024
Employer Active
1 Vacancy
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Job Description
Accountabilities:
As a Quality Engineer Specialist, you will facilitate and guide cross-functional team members in the use of available quality risk management tools, including FMEA, PHA, RR&F. You will collaborate with project teams and necessary departments to complete risk assessments and lead teams in identifying mitigations. You will evaluate product data for their impact on the current quality risk management files and author and review quality risk management plans, reports, and risk assessments. You will also ensure that all AstraZeneca policy and procedures for the Risk Management Program are followed at the site level.
Essential Skills/Experience:
- Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 2 years of experience in a pharmaceutical or FDA regulated environment.
- Familiarity with global regulatory agencies’ requirements for Quality Risk Management and Quality Systems (ICH Q9, GAMP5, 21CFR 11/210/211)
- Ability to prioritize, manage and follow-up on numerous projects and activities
- Effective written and verbal communication skills
- Excellent technical writing experience in a regulatory environment
- Detail oriented and exhibit a high degree of flexibility and initiative
- Ability to function efficiently in a diverse, fast paced, changing environment
- Ability to work independently as well as part of a team
- Ability to think critically, and utilize troubleshooting and problem solving skills
- Desired Skills/Experience:
- Masters degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field)
- Cell and Gene Therapy experience is a plus
Employment Type
Full-time
Department / Functional Area
Key Skills
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