Role DescriptionYou will be responsible for ensuring compliance to GxP requirements across different countries in the CEMEA region. You will fulfill a key role in further developing, implementing and optimizing the CEMEA regional Quality System, supporting affiliates and maintaining GMP/ GDP licenses. You will also be responsible for the quality support of third-party contract organizations and service providers
ResponsibilitiesYou will be responsible for operational QA activities including deviations, temperature excursions, CAPAs and changes; You will provide support in maintaining the Quality Management System and all operating licenses Provide Quality support to affiliates, including inspection management, maintenance of an adequate Quality Management System, eQMS user support and management of intra-company Quality Agreements; Perform and participate in internal/external audits; Support the management of complaints, quality issues and recalls; Monitor and report Quality KPI’s for the region and support Quality System Management Reviews; Provide quality support to third parties in the CEMEA region (manufacturing/ packaging facilities, logistic service providers), including qualification/ validation, auditing, product transfer and contract management activities; Implement local continuous process excellence and improvement activities for the region; Support new product launches; Manage local and regional projects.
RequirementsMasters or Ph.D. preferably in life sciences (e.g. Pharmacy, Biology or Chemistry); 3-5 years Pharmaceutical industry experience in various local and/or global Quality and ideally manufacturing or supply chain roles roles; A deep understanding of Pharmaceutical GxP processes and regulatory requirements in Europe and possibly other regions; Ability to drive and manage issues, complaints, CAPAs and changes through to satisfactory conclusion; Experience with building and implementing lean processes in full compliance with regulatory requirements; Computer literate, the role holder will need to work in standard office software, SAP, eQMS and any other systems necessary to complete the activities required; Fluent in written and spoken English, additional languages are a plus; Ability to communicate effectively through verbal and written media; Ability to interact with personnel of all levels, including customers; Excellent organizational, interpersonal, influencing and listening skills; Ability to travel according to business needs
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.