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Qa operational team lead

Dundee (DD2 9)
Posted: 10h ago
Offer description

About us: At Argenta, we’re more than a company — we’re a global team dedicated to healthier animals. Founded in 2006 by a New Zealand chemist with an entrepreneurial mindset, our vision is simple yet powerful: “Healthy Animals, Let’s Make it Happen Together.” We partner with clients in Research, Development & Innovation (RD&I) and Manufacturing to produce pharmaceuticals for both farm and companion animals. Argenta now has operations across the globe with locations in New Zealand, the United States, Scotland, Germany, and Spain with 900 employees globally. About the Role: Argenta is currently looking to fill the role of QA Operational Team Lead onsite at our Dundee location. This role will work collaboratively with the Head of Quality Assurance, to help lead the Quality Assurance Specialists to ensure the cGMP compliance status of the site, while maintaining the safe and cost effective fulfilment of customer quality requirements. Key Accountabilities: Manage the QA activities for the batch release process to ensure all documentation is checked and available for QP release to meet the OTIF requirements. Manage the QA activities for Disposition of raw materials and packaging and to ensure all materials are available when required. Manage the QA activities to ensure documentation reviews and feedback are performed in a timely manner. Manage the QA activities to ensure the sites ongoing FUST Stability programme is met. Manage the QA team and Identify training and development opportunities for the team. Manage and resolve material quality issues that arise and are escalated from the site Manage and have oversight of the Quality compliance systems to ensure compliant with customer requirements. Deviation Management and CAPA system(s). Participate in Investigates, provide guidance, report and approve operational deviations, working with internal stakeholders & external partners to resolve issues and identify effective CAPA’s in a timely manner. Review, advise and approve effective change control actions across the Dundee Facility ensuring compliance with the necessary regulations. Write/revise/approve and give advice on quality documentation (i.e. batch records, product specifications, packaging specifications, annual product quality reviews, stability & validation protocol(s)) Identifies revisions / new procedures that impact cGMP activities, as required and ensures the relevant departmental standard operating procedures (SOP’s) are complete & accurate. Support the Dundee audit platform, for both internal & external audit and ensuring compliance to the annual self- assessment / self-audit platform as defined by the Site Quality team Support new project and product introductions on site. Ensuring they are onboarded in a compliant manner Support the continuous improvement platform for manufacturing, by providing technical support on quality framework(s) and collaborating across the business to reinforce a progressive quality culture Comply with all company local and global policies including Quality frameworks and health, safety and environment (HSE) policies. Perform any other duties or serve in such other capacity as may be determined by Company management Qualifications: Relevant tertiary qualification in scientific discipline Knowledge/Experience: Good leadership, communication, negotiation and influencing skills Industry experience, preferably Pharmaceuticals. Good knowledge and understanding of cGMP, quality systems and quality practices associated with production, analytical testing and documentation Ability to work with competing priorities and achieve multiple deadlines / timeframes Driving accountability for performance of team members Ability to manage resources to meet changing priorities Ability to work independently and employ the initiative to find solutions, prioritise and exercise discretion Has a proactive and flexible approach to work For more information visit us at www.argentaglobal.com

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