Job Title
A Quality Assurance Specialist plays a pivotal role in ensuring the quality and compliance of Ennogen's pharmaceutical and medical device products.
Key Responsibilities:
* Perform QA release of food supplements and cosmetics, scrutinizing documentation for adherence to GMP standards.
* Conduct thorough reviews of batch documents for medical devices and medicinal products prior to PRRC/RPi/QP release, guaranteeing accuracy and compliance.
* Participate in critical aspects of the quality management system, including self-inspections/Internal Audits, regulatory inspections, and customer complaints investigations.
* Raise and perform change controls, Deviations, Non-Conformances, and CAPAs as required for batch release, ensuring prompt incident reporting, investigation, and closure.
* Maintain precise storage of key quality information, reviewing monthly temperature reports, and retaining storage samples as necessary.
* Compile 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.
* Manage and collate electronic Product Master Files, collaborating with project managers.
Requirements:
* HNC or degree level education in a relevant field.
* Three - Five years of experience in a Quality Related function within the Pharmaceutical Medicinal Product or Medical Devices Industries.
* Exceptional interpersonal skills and ability to work independently or as part of a team.
* Excellent attention to detail.
* Knowledge of quality systems and working knowledge of Microsoft office packages and root cause analysis tools.
Salary Information:
* This role is offered at an annual salary of £32,500, inclusive of benefits.