expectations. Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA...
, quality, and regulatory stakeholders. Compliance & Documentation Ensure schedules reflect FDA, EMA, EU Annex 15, and ISPE...
, quality, and regulatory stakeholders. Compliance & Documentation Ensure schedules reflect FDA, EMA, EU Annex 15, and ISPE...
, ICH guidelines, and regulatory requirements (FDA, EMA) Understanding of clinical trial processes and adverse event reporting...
. Compliance & Documentation Ensure schedules reflect FDA, EMA, EU Annex 15, and ISPE requirements. Support audit readiness...
Authority inspections (FDA/EMA), and support the execution of corrective action plans. Apply risk management processes...
expectations. Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA...
. Compliance & Documentation Ensure schedules reflect FDA, EMA, EU Annex 15, and ISPE requirements. Support audit readiness...
(FDA, EMA, ICH) and comply with Gilead’s Quality System and cGMP principles. Assess packaging designs and qualifications...
and regulatory requirements. · Support internal audits and regulatory inspections (FDA/EMA). · Identify compliance gaps, perform...