• Works in the External Biological QA team of Shire United States (US) Quality Assurance supporting, packing and labeling operations, batch release, warehouse operations and logistics performed
• The QA Specialist is responsible for support of appropriate procedures and policies for batch record review and product disposition according to the relevant regional regulations
• Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, and BRAVE values.
Responsibilities-
• This position is responsible for monitoring and supporting batch disposition of bulk drug products (DP) and finished drug products (FDP)
• The individual may be responsible for, but is not limited to: Conducting record review of executed batch records for finish drug products to support CMO packaging & labeling record review
• Performing review of bulk drug product executed records, if needed
• Prepares all paper work for product disposition (bulk and finished product) and performed assessments for impact to disposition from deviations and change controls
• Reviews and approve deviations and change controls related to DP and FDP
• May own CAPAs associated within the QA unit
• Supports drug product and finish drug product annual review report sections
• Understanding of GMP’s
• Supports departmental projects as needed