Quality Specialist

Ennogen, founded in 2011, is a fast-growing international pharmaceutical and medical device company with a focus on reinvigorating heritage brands to meet under-served clinical need. At the core of everything we do is our purpose to improve the lives of our patient communities around the world.

In this role, you will be a part of Ennogen's Quality team, who are central to Ennogen's operations. Quality is a priority at Ennogen and as such we are committed to ensuring our Quality team is made up of highly-skilled and dedicated individuals that are committed to achieving excellence through teamwork.

Job Purpose:

• To assist the QA Managers and other QA team members in the implementation of all aspects of the Generics Quality System.
• To work with all departments operating out of Ennogen's Kent office to ensure that GMP practices are current and in compliance with the current guidelines.
• To carry out QA approval of appropriate product for release as required.

Key Responsibilities are detailed below:

• Perform QA release of food supplements and cosmetics
• Perform QA review of batch documents for medical devices and medicinal products prior to PRRC/RPi/QP release
• Participate in vital aspects of the quality management system, for example perform self-inspections/Internal Audits and participate in audits as required, as well as assisting in Regulatory and Customer Inspections and Customer Complaints Investigations.
• Raise and perform change controls, Deviations, Non-Conformances and CAPAs as required for batch release, ensuring that incidents are reported, investigated and closed in a timely manner.
• Maintain the correct storage of key quality information such as hard copies of quality documents, reviewing the monthly temperature report as well as maintaining the correct storage of the retained storage sample.
• Collate Key Performance Indicator information and trends for the Quality Management Review Meetings related to batch release.
• Perform and maintain Supply Chain Risk Assessments, excipient risk assessments and TSE statements.
• Maintain and collate electronic Product Master Files working with project managers.

Qualifications and Skills:

• HNC or degree level education
• Three - Five years working in a Quality Related function in the Pharmaceutical Medicinal Product or Medical Devices Industries
• Excellent interpersonal skills and the ability to work as part of a team or independently to deadlines
• Excellent attention to detail
• Knowledge of quality systems
• Working knowledge of Microsoft office packages and root cause analysis tools

Pay Range:

• This job will pay £30 - £35k per annum + Benefits