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My client a growing international medical device company is looking for a Quality Operations Manager to join one of their office based in Vaud canton. Responsibilities: · Direct and manage the QA operations team · Coach and mentor employees to optimum performance, and recruit and interview qualified applicants, ensure appropriate new-hire training and orientation, and provide on-going training and development of Quality Team. · Identify and/or facilitate implementation of quality improvements or projects in accordance with cGXP and applicable standards expectations and evolutions to improve compliance, quality levels, and improve operational efficiencies. · Activities include, but are not limited to: creation, review, or approval and implementation of Standard Operating Procedures, creation and delivery of training, supporting resolution of quality issues and CAPAs · Monitor quality metrics to identify systemic issues in the batch release process and assuring appropriate investigation, correction, and corrective and preventive action when needed. · Support internal and external audit activities, to include pre-audit planning, including development of audit plans, audit execution and evaluation and post-audit follow up and recommendations. · Ensure applicability of current company policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable global, federal, and local regulations Your profile: ? Bachelor's Degree, preferably in Life Sciences, chemistry or related relevant degree. Equivalent combination of relevant education and applicable job experience may be considered ? Minimum 7+ years of Quality Assurance experience in a GXP related field within the biotechnology, biologics, or pharmaceutical industry ? Experience in leading a quality operations unit that operated in full compliance with global cGMP requirements and successfully managed inspections from major Health Authorities including USA, EMEA, Canada, Brazil. ? Experience reviewing and releasing Final Product ? Six Sigma green belt/black belt preferred. ? In-depth knowledge of cGMP, GDP, FDA Part 820 and ISO13485:2016 requirements ? Ability to interpret and relate Quality standards for implementation and review ? Solid understanding of Deviation, CAPA, Change Control processes ? Familiar with process improvement, Six Sigma, product and process validation, SPC. ? Business fluent English in written and spoken ? Proficient in MS Office products and in SAP
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