At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

Britannia Pharmaceuticals, part of the STADA Arzneimittel AG group of companies, is a UK based pharmaceutical company specialising in the neurology market. Britannia focuses on innovative products for chronic and serious medical conditions, and in particular, the treatment of Parkinson’s disease. We are highly committed to improving the quality of life for People with Parkinson's disease.

Quality Assurance Officer   

Reading | United Kingdom (GB) | Full-time | Permanent 

We are seeking a dedicated Quality Assurance Officer to support our pharmaceutical and Quality Management System (QMS) activities. The ideal candidate will be responsible for ensuring the accuracy and quality of all associated documentation, which is essential for manufacturing, batch disposition, stability, and regulatory submission packages. 

Key Responsibilties: 

As a Quality Assurance Officer, you will:

• Provide support for day-to-day operation of the Quality Assurance department.
• Operate in accordance to GMP.
• Deliver direct quality team support during customer and regulatory audits.
• Assist in third party audits as required.
• Support the collation, processing, review and trending of quality complaints, process deviations, non-conformances, QMS actions and change controls.
• Collate Annual Product Quality Reviews for QP review and approval.
• Participate in Self-Inspection audits of Britannia Departments including Quality Assurance.
• Collate and review batch release documentation for medical devices and medicinal products.
• Issue, maintain and archive GxP documentation in accordance with company Documentation Management System.
• Populate QMS metrics.
• Provide support to internal and external customers as required.
• Adhere to company documentation policies and maintaining documentation systems as required.
• Ensure that all work is conducted in accordance with compliance procedures, legislation, and regulatory requirements, including but not limited to directives and guidance such as PMCPA, NMC, APBI Code of Practice, GMDP, and other GxPs.

Qualifications & Skills:

          Essential

• Scientific background either via experience or qualification.
• Excellent oral and written communication skills.
• Must be a self-starter who can take general concepts and direction and produce desirable results.
• Proficient in use of various computer software, such as Microsoft Word, Excel and PowerPoint.
• Demonstrate attention to detail.
• Experience within manufacturing environment with demonstrated ability to understand process or technical documentation.
• Able to prioritise workload, decisive thinker able to work within agreed timescales.
• Ability to work both independently and as a team member.
• Solid understanding of applicable EU Regulations, Directives and Guidance pertaining to GMP and GDP.

          Desirable

• Experience of working within a Medical device, GMP, ISO 9001 or ISO 13485 background
• Internal auditor trained / experienced
• Experience of reviewing/ updating production documentation, SOPs or similar.
• Demonstrated working knowledge of compliance, quality and manufacturing documentation requirements
• Experience in use of eQMS systems

This role is based from our office in Reading - We offer hyrbrid working, 3 days at our office in Reading on a Monday, Tuesday and Thursday with Wednesday and Friday remotely. 

Are you looking for new challenges where you can make a difference for people’s health? We are looking for candidates with positive attitude, expert knowledge and an entrepreneurial spirit that enjoy friendly working environment in a global team. We would be pleased to get to know you. Please use our online job portal to submit your application: https://jobs.stada.com