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Quality and Regulatory Officer
3 months ago
The Senior Quality Assurance Officer will conduct, coordinate and support quality aspects of the Company's business operation, ensuring quality compliance throughout the business with a focus on WDA, MIA GMP and GDP activities.
Key Responsibilities:
To ensure that a quality management system is implemented and maintained and appropriate to the activities at the Company inclusive of the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C343/01) and EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.
Providing compliance support and spreading the quality culture throughout the company.Maintain processes (GMP documentation lifecycle, Change Control, Deviation, CAPA, self-inspections, Complaints, GMP document control and training) needed for successful site compliance with the PQS.
Participating in reviews and suggesting improvements delving into areas of continuous growth.Responsible for updating & maintaining QMS-related trackers.
Ensure that the company operates in compliance with the authorised activities on the WDA and MIA licenses.
Ensure that own premises and other contracted storage premises uphold necessary standards of GDP and GMP.
Ensure quality, safety, integrity and security of legal categories of medicinal products named on the Marketing Authorisation and Controlled Drug Licence.
Ensure procedure for the retention of documentation with procedures comprehensively written and understood by applicable staff.Ensure the appropriate storage of GxP documentation. Act as the primary company archivist. Ensure appropriate process is in place for the recall of documents when requested.
Ensure the effectiveness of the procedure for identification and documented reporting of product quality complaints, product recalls and handling of suspected falsified medicines.
Support the collation and review of product quality documentation and technical data to check that products remain safe, compliant and of a high standard for supply.
Qualifications, Experience &Knowledge Required:
Proven Quality Assurance experience in the pharmaceutical industry, with a solid foundation in QA principles.
Strong analytical skills and keen attention to detail to identify and address potential quality issues.
Proficient writing skills, using appropriate software tools to develop and edit documents, procedures, and reports, contributing to comprehensive documentation and compliance.
Understand the role of the MHRA (and other competent authorities) in the licensing of medicines, the risk-based inspection process, the role of the enforcement group, the Inspection Action (IAG) and resulting actions that can be taken due to non-compliance.
Good understanding of GMP / GDP.Excellent attention to detail.
Effective time management.
Self-motivated & highly target driven.
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