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About Argenta Argenta is a global team dedicated to healthier animals. Founded in 2006, we partner with clients in Research, Development & Innovation (RD&I) and Manufacturing to produce pharmaceuticals for both farm and companion animals. Argenta operates across 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 OTIF requirements.
* Manage the QA activities for disposition of raw materials and packaging to ensure all materials are available when required.
* Manage QA activities to ensure documentation reviews and feedback are performed in a timely manner.
* Manage QA activities to ensure the site’s 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.
* Oversight of Quality compliance systems to ensure compliance with customer requirements.
* Deviation Management and CAPA system(s). Participate in investigations, provide guidance, report and approve operational deviations, working with internal stakeholders and external partners to resolve issues and identify effective CAPAs 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 (e.g., batch records, product specifications, packaging specifications, annual product quality reviews, stability & validation protocol(s)).
* Identify revisions/new procedures that impact cGMP activities, ensure relevant SOPs are complete & accurate.
* Support the Dundee audit platform for internal & external audits and assist with the annual self-assessment/self-audit platform defined by the Site Quality team.
* Support new project and product introductions on site, ensuring onboarding is compliant.
* Support the continuous improvement platform for manufacturing by providing technical support on quality frameworks and collaborating to reinforce a progressive quality culture.
* Comply with all company policies including Quality frameworks and health, safety and environment (HSE) policies.
* Perform any other duties as determined by Company management.
Qualifications
* Relevant tertiary qualification in a 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 the performance of team members.
* Ability to manage resources to meet changing priorities.
* Ability to work independently and use initiative to find solutions, prioritise and exercise discretion.
* Proactive and flexible approach to work.
For more information visit us at www.argentaglobal.com
Seniority level
* Mid-Senior level
Employment type
* Other
Job function
* Quality Assurance
* Industries
* Pharmaceutical Manufacturing
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Dundee, Scotland, United Kingdom – 2 weeks ago
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