Saint Petersburg, FLToday
Role/pulliManage complex and high-level proactive compliance initiatives and continuous improvement efforts in collaboration with internal Catalent stakeholders./liliProvide leadership support and oversight to Quality teams responsible for CAPA management and batch record review and release activities./liliProvide lead investigator, reviewer/approver, mentorship/coaching, rapid response, operational excellence analysis, technical writing, preventive action planning, and compliance monitoring systems (e.g., TrackWise) training./liliEnsure site proactive compliance initiative training programs meet regulatory and customer requirements./liliRecommend and drive process improvements based on trend data from CAPAs, complaints, investigations, audits, and quality metrics./liliPerform advanced review of supporting documentation including batch documentation, test results, specifications, training records, SOPs, calibration records, and validation documentation./liliParticipate in site quality initiatives and support Management Review and metric reporting activities./liliOther duties as assigned./li/ulpThe Candidate/pulliBachelors Degree in Science or related field required (Chemistry, Microbiology or Biology); with a minimum of five years related experience in QA pharmaceutical manufacturing./liliPrior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred)./liliQuality