Overview
QA Officer Jobs in United Kingdom at Exeltis UK
Title: QA Officer
Company: Exeltis UK
Location: United Kingdom
About the Company
Exeltis is part of the Insud Pharma Group of biopharmaceutical organisations, with over 40 years of experience and operations in more than 50 countries. Exeltis UK was established in 2022 to bring Exeltis products to the UK market, Our product portfolio spans HRT, pregnancy and sexual health, with a healthy pipeline and we are committed to finding clinical solutions to meet the unmet needs for women across key stages of their sexual and reproductive lives. This is an exciting phase in which to join Exeltis to realise their ambitions to become leaders in Women’s Health medicine and contribute to the strategy and culture that will lead to this success. We are looking for an experienced, and enthusiastic QA Officer to drive the performance of our innovative new contraceptive and successive contraceptive products
About the Role
We are seeking a detail-oriented QA Officer to support the Quality Assurance team with the maintenance of the Quality Management System. The ideal candidate will assist in documentation control and process improvements to ensure adherence to Good Distribution Practices (GDP) and other industry guidelines.
*Remote, with initial training in London and thereafter requiring attendance at the London office twice a month.
*This is an entry-level internship position with an annual salary of £23,810. The role will be a 1-year contract with potential flexibility to extend.
Role profile
Act as document controller for the document control process (lifecycle management of standard operating procedures (SOP’s), forms, templates, etc.)
Documentation support including but not limited to:
The creation and amendment of quality department forms, templates, and SOPs
Co-ordinate the approval, authorisation and maintenance of SOPs, Templates, Forms Quality Policy and Quality Manual
Ensure timely review, approval, and archiving of QA documents to comply with regulatory standards.
Manage the QMS Administration – recording, filing, chasing, updating logs, trackers etc for several processes:
Change Control, Deviations, Product complaints, CAPA and Audit Programme(s), Self-inspection, Supplier Audits, Quality Technical Agreements, training records and Product Release documentation
Support the creation and management of training plans and training matrices where required.
Assist in customer and supplier qualification processes by maintaining relevant records and documentation.
Provide appropriate quality data to support Key Performance Indicators and create periodic QMS reports.
Support inspection readiness activities – preparation and follow up of readiness actions
Track and follow up on audit findings and corrective actions.
Assist in implementing process improvements to enhance quality and efficiency.
Qualifications
Education: Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemistry) or equivalent experience (essential)
Specific Knowledge: Knowledge of MHRA, GDP and other regulatory guidelines is an advantage (desirable).
Personal skills: Strong organizational and administrative skills with high attention to detail (essential).
Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and document management systems (essential).
Excellent communication and interpersonal skills (essential).
