Quality Assurance Lead

vor 4 Wochen

Melbourne, Österreich CHR Life Sciences Vollzeit
CHR Life Sciences is excited to be partnered with a growing business operating across all the GxPs providing a turnkey (end-to-end) solution to clients by offering support throughout the product life cycle and manufacturing process. They are passionate about patient safety and welfare, and genuinely care for clients and provide them with the highest standards through consistency, ambition and technical competency throughout the company.This is a full-time opportunity based on-site for an experienced QA Specialist/Lead. Looking for a professional with a "can-do attitude" to provide SME support to our quality function. Reporting to the Quality Manager, you will bring the enthusiasm required to ensure the organisation's products meet all quality requirements.Job Summary :The role involves leading a team responsible for all aspects of the quality function, ensuring compliance with relevant standards. You will be responsible for continual quality improvement, ensuring our products meet all requirements before reaching the client. Taking the lead across a range of Good Manufacturing and Distribution activities, delivering quality reports and products in line with documented methodologies, procedures, regulations and guidance. You will be a key point of contact for the management of Quality Assurance provision.As the Quality Specialist/Lead you shall:Provide Leadership, support and guidance in relation to all Quality matters.Manage the site Qualtiy Management System and ensure lead/execution for progression of site-related deviations, change controls, associated risk assessments and CAPAs thereof.Ensure that the operations of the business and associated supply chain meet the relevant standards, including validation activities when required.Ensure products meet established quality standards and industry benchmarks.Handle complaints effectivelyDemonstrate effective relationship management between GMPM and external parties.Oversee all external and internal audits, including the management of competent authority inspections.Be responsible for site trainingAdhere to Health and Safety guidelines as well as legal requirements.Follow the company's core values, ensuring objectives are met.Any other duties that may reasonably be required.Client travel may be required as necessary and when applicable.What You Need:A minimum of 5-10 years' experience in a Quality Assurance role within a pharmaceutical manufacturing environment preferably creams and liquids dosage forms.Knowledge of Human Medicines Regulations/Medical Device Regulations, Good Manufacturing Practice, Good Distribution Practice, ISO 9001, ISO 13485.Team Management within a quality environmentLeadership SkillsManagement SkillsOversight of day-to-day Quality activitiesPreferred but Not Essential:A degree-level qualification in a related subject preferably in pharmaceutical science.Understanding of medicinal drug products/medical device supply chains and associated external relationships.Experience of delivering trainingProject ManagementPersonal Characteristics:Excellent organisational skillsLead by example through the demonstration of the company's core values.If you feel you are the right person for this role, please don't hesitate to apply below with an up-to-date CV attached.

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