Quality Officer
About the Company
Exeltis is part of the Insud Pharma Group of biopharmaceutical organizations, 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 menopause, pregnancy, sexual health and CNS, 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.
Role Purpose
The QA Officer position sits within the Quality, Regulatory and Safety Department and will work collaboratively with the Quality Assurance Manager to maintain and operate the Quality Management System (QMS) to ensure full compliance with MHRA and Good Distribution Practice (GDP) regulations and guidelines, and internal company standards. The role is hands-on, detail oriented, and integral to ensuring quality, compliance, and inspection readiness across the UK affiliate.
Specific Responsibilities
Quality Management System (QMS) Support
- Act as document controller for the lifecycle management of SOPs, templates, forms, Quality Manual and Quality Policy.
- Coordinate documentation creation, review, approval, version control, archiving and periodic review cycles.
- Maintain the administration of forms, logs, records for Change Controls, Deviations, CAPA, Complaints, Audits, Training Records, Supplier/Customer Qualifications, Returns & Destructions.
Operational Quality Activities
- Support internal and external audits, including preparation, follow-up actions and tracking of CAPAs.
- Contribute to inspection readiness activities and ensure evidence and documentation are up to date.
- Assist with customers and supplier qualification activities by maintaining records and ensuring required documentation is complete.
Training and Support
- Support creation and maintenance of training plans, training matrices, and associated documentation
- Support QMS KPI reporting by collating and presenting relevant quality data.
Competencies and personal skills/attributes required for the role
- 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 organisational 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).
Company benefits
- Competitive salary
- Annual performance bonus
- Pension contributions
- Private medical insurance
- Income protection & life assurance
- 25 days’ annual leave, plus 3 additional days between Christmas and New Year
How to Apply
Please email your CV to: stephen@pccjobs.uk
Job code: EXE-E/INP-CORP-2801-v1 March 2026
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