Azienda Importante Multinazionale Farmaceutica (Big Pharma)
Job Description This position leads and manages the Quality Compliance Team composed of people mainly focused on shopfloor activities (batch record review, deviations management, change control management etc.) by developing and implementing systems and work flow for the review of batch documents, and work in conjunction with the Company stakeholders to operate a synchronized business process that ensures that batch related production documents are prepared, reviewed, and compliant with Company policies, procedures and standards. This role is a direct reporting of Site Quality Head.
Main responsibilities: Oversee of the deviation management processReview and provide approval of SOPs, Master Batch Records, Specifications and other controlled documentsEstablish goals for the QA and Compliance Specialists in partnership for measuring and reporting group performance, and developing process improvements as necessaryWork collaboratively with Operations and Quality Control in order to develop review criteria and lead times as products are introducedCarry out supervisory responsibilities of a team of QA and Compliance Specialists in accordance with the organization's policies and applicable laws; responsibilities planning, assigning and directing work; appraising performance; rewarding, developing and disciplining employees; addressing complaints and resolving issues; the position will staff, train and manage a group of QA Specialists, Compliance Specialists and Document Control Clerks in order to perform the tasks in accordance with established standard lead timesAdminister, document and maintain conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems and tools, as well as direct actionsReview/Approve Manufacturing Documents (Master Batch Records, Executed Batch Records) and deviation managementAnalyze and assist with the resolution of existing/potential quality-related issuesPrepare metrics for Batch Release, Investigations, and Deviations Competenze ed esperienza About you Experience: minimum of 7 years of pharmaceutical experience in sterile manufacturing quality assurance or quality control, or an equivalent combination of education and experienceSoftSkills: leadership, Team working, Problem Solving and Change Management with a strong attitude to Continuous ImprovementTechnical Skills: demonstrated proficiency in interpretations of cGMP regulations, both EU/US and international; LeanSS Certification will be considered a plusEducation: BS (Bachelor of Science) in Chemistry, Life Sciences or relatedCertification: the candidate must have authorization to act as EU Qualified Person or has the requirements to obtain the Qualified Person appointmentLanguages: fluent English in speaking and writing Completa l'offerta Excellent growth opportunities
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