Quality Assurance Specialist
1 month ago
At Argenta we have a passion for what we do, and we relish a challenge. Are you an experienced quality assurance specialist looking for a new opportunity?_
So who are Argenta? Founded in 2006 by a New Zealand chemist with an entrepreneurial mind, his vision was to touch lives all over the world by the creation, development and production of the best animal health technologies and products. Our vision and our people are unique and are the key to our success to date.
Argenta has continued to grow operations across 6 sites with locations in New Zealand, the United States, UK and Europe with over 600 employees globally.
An opportunity has become available for a permanent full time Quality Assurance Specialist within the Quality Assurance Department at Argenta Dundee.
You duties will include:
- Review analytical data and other data relating to Raw Materials, Intermediates, water and packaging, trend data and perform disposition.
- 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 and provide feedback on Laboratory Investigation Reports and perform QA approval.
- Review and approve updates to QC documentation e.g. Raw Material specs, Finished Product Specifications, MOAs, Stability protocols and reports
- Review and Approve QC Validation Documentation
- 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 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.
What are we looking for:
- Science Degree (Chemistry, Pharmacy, Biology)
- Industry, preferably Pharmaceuticals.
- Good knowledge and understanding of cGMP, quality systems and quality practices associated with deviations, change control, validation including CSV, Vendor Qualification, batch record reviews and Annual Product Reviews.
- Ability to work with competing priorities and achieve multiple deadlines / timeframes
- Effective communication, negotiation and influencing skills
- Ability to work independently and employ the initiative to find solutions, prioritise and exercise discretion
- Strong attention to detail with a record of driving quality performance with a quality focussed attitude
We look forward to hearing from you
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