Key Duties and Responsibilities • Maintains Investigation, CAPA, Complaints, Change Control systems logs. • Leads and reviews investigations (deviations, excursions, complaints). Ensures CAPAs are assigned and followed through. • Perform primary quality batch record review. • Assists in the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. • Review and approval of quality related documents. • Assists in collection of data for Annual Product Reviews. • Writes Annual Product Reviews. • Leads by example and proactively communicates and collaborates with internal staff, colleagues, and external stakeholders to drive results. • Monitors Quality Systems and advises Quality Compliance supervisor on system performance; publishes statistics regarding performance against set goals and makes recommendations. • Trending of Quality metrics. • Performs trainings on various GMP related topics as needed. • Other duties as assigned.
Qualifications Education/Experience • Bachelor's degree in sciences or related field required, Bachelor's degree in Microbiology preferred • 2-3 years’ relevant experience in a regulated Pharmaceutical industry including Quality Systems, Quality Assurance, Quality Control. • Experience in an aseptic manufacturing facility is desirable • Combinations of related education and experience may be considered Technical/Behavioral • Knowledge of cGMP, Quality Systems (CAPA, Investigations, Complaints, Change Control), Drug Regulatory Affairs, manufacturing and packaging processes required. • Knowledge of process validation, microbiology and chemistry preferred. • Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally. • Ability to communicate effectively defending quality initiatives and compliance a plus.