QA Specialist for External Quality
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Job Type | Contractor |
Area | Dublin |
Sector | Quality |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | #2233 |
Job Views | 440 |
- Description
Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred including QA validation experience; consideration will be given to other relevant experience and education
Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment
Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing. Minimum of 2-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
Experience working with contract manufacturing organisations
Ability to provide project leadership and guide successful completion of Quality projects
Excellent written and verbal communication and negotiating skills
Risk assessment and risk management
Ability to exercise judgment with defined procedures and practices to determine appropriate action
Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
Ability to monitor and report on assigned tasks, goals, and objectives.