Contracting – Brabant Wallon
BACK-UP FUNCTIONThe position can act as back-up for his direct colleagues after appropriate trainingOPERATIONAL QA ROLEAssure that intermediates and active pharmaceuticals products get produced and released in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)Follow up of product related: change control, failure investigation, deviations, CAPA and action plans, qualification of dedicated equipment (protocols and reports)Review of batch record from intermediates to drug substanceBatch disposition of chemical intermediates (DS manufacturing)Review of master batch records and specificationsCONTINUOUS IMPROVEMENTSupport the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operationsDrive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the site.Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projectsPromote quality and operational excellence and cultivate "Compliance Awareness", "Continuous Improvement Attitude" & "Accountability Culture" across the BPM and related supporting servicesEnsure general cGMP training of internal customersDrive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirementsEnsure communication of compliance status and issues to appropriate levels of the organizationEnsure a relevant cGMP level regarding subcontractors used to support routine operations for BPM and related supporting servicesParticipate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections
Min 3 years experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health related fieldExperience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industryExperience with Quality Management SystemAbility to balance multiple priorities, provide leadership and prioritization, and work with minimal supervisionExcellent team player attitude with excellent interpersonal relationship and communication skillsAbility to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetingsFluent in French and English
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply or send me your CV, lena.palmeri@jeffersonwells.beFDA, Protocols, Pharmaceuticals, Prioritize Workload, Process Equipment, Process Management, Manufacturing, Masterbatch, Investigations, Projects, Development, Ability to Plan, Support Network, Internal Customers, Communication, System Process, Leadership, Operations, PIC, Technical work, Quality assurance, Equipment support, Pharmaceuticals, Support Systems, Communication, DS, Health System, Communication, Exploit, Audit Observations, Risk Identification, Quality assurance, Inspection, Regulation, Pharmaceuticals, Investigations, Training, VOS, Quality Control, EMEA, cGMP, Best Practices, Life Science, Direct support, Management, Disposition, Production, Service, Change Control, Accountability, CAPA, Batch Records