QA Specialist for External Quality

2021-11-03 15:21:052049-03-19Team Horizon
Job TypeContractor
Start Date
AdvertiserAshling Guthrie
Job Ref#2233
Job Views367
  • 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.
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