Process Compliance and Risk Mitigation

Descripción de la oferta

Job Description

Responsible for deviation and incident management for CMO&PS, including monitoring of timely completion of investigation and effectiveness of corrective and preventative actions (CAPAs). Supports with risk assessment activities and process improvement initiatives.
Manage CMO&PS deviations and quality incidents (across Novartis Divisions) through • Tracking receipt of deviations and incidents • Entry in to Adaptable Quality Workflow Application (AQWA) • Overseeing timely completion of investigations • Overseeing implementation of appropriate CAPAs and availability of appropriate evi-dence • Verifying appropriateness and completion of effectiveness checks • Timely closure in AQWA Lead projects related to Safety Systems/AQWA/CAPA applications including contributing to test-ing activities. Work closely with Quality Assurance (QA) and process owners to perform investigations and de-velop appropriate CAPAs and effectiveness checks. Collaborate with the Compliance & Quality function to produce metrics and complete trend anal-yses designed to identify areas of risk within the CMO&PS organization with regards to process compliance. Monitor compliance of the CMO&PS organization to deviation and quality incident handling pro-cesses and standards and where deficiencies are implement strategies to address these. Manage the Deviation and Incident Review meetings; Schedule the meetings, prepare the agenda and track and follow up on actions. Achieve efficiency gains through continuously improving and simplifying the processes used to track deviations and quality incidents. Prepare guidance documents and training material to educate CMO&PS associates on the devia-tion and quality incident process. Train and mentor CMO&PS associates as well as associates from other global line functions as needed on the deviation and incident management process as well as risk identification and mit-igation strategies. Act as a subject matter expert during inspections (e.g. FDA and EMA) and audits and, support with post audit/inspection activities including drafting of responses to any findings and the im-plementation of CAPAs. Alert the Head Process Compliance and Risk Mitigation to potential compliance issues
Position Title

Process Compliance and Risk Mitigation

Perfil buscado

Minimum requirements

PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable. • Minimum 2 to 4 years of experience in the pharmaceuti-cal industry, particularly pharmacovigilance • Experience of dealing with incidents and deviations, inves-tigating root causes and developing appropriate CAPAs • Experience of managing process change / projects within a matrix environment • Excellent analytic skills • Good communication and presentation skills • Good organizational skills • Ability to mentor and coach
Job Type

Full Time
Country

Spain
Work Location

Barcelona Gran Vía
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

CMO & PATIENT SAFETY GDD
Employment Type

Regular
Company/Legal Entity

Novartis Farmacéutica, S.A.