Pharmadox Healthcare Ltd is an EU cGMP-licensed importation, secondary packaging, batch testing and batch release service provider to the global pharmaceutical industry. Having one of the largest and most established facilities in the EU, catering for non-sterile, sterile and inhaler (MDIs / DPIs) pharmaceutical products, the company is seeking to expand its operations further and extensively. To substantiate company growth, the following vacancy has arisen.

Role Summary

The Quality Assurance Officer (QMS) is responsible for supporting and maintaining the Company's Quality Management System (QMS) in compliance with applicable GMP requirements, internal procedures and regulatory standards.

The role focuses on the effective management of quality systems, documentation, change control, deviations, CAPA, training, quality records and other QMS activities to ensure that Pharmadox Healthcare maintains a high standard of quality, compliance and product safety.

Key Responsibilities

Manage and maintain the Company's Document Control and Change Control systems, ensuring that all relevant documents, records and changes are appropriately controlled, reviewed, approved and maintained.
Maintain and support the Company's Quality Management System (QMS) through the preparation, review, updating and control of quality documentation, including SOPs, the Site Master File and other controlled documents.
Assist in the management, investigation and follow-up of deviations, investigations, CAPAs, complaints, KPIs, Product Quality Reviews (PQRs), Product Master Files and other quality-related activities.
Review Secondary Packaging Batch Document Records to ensure that documentation is complete, accurate and compliant with approved procedures and GMP requirements.
Manage and maintain the Company's Technical, Service and Confidential Agreements, ensuring that records are appropriately organised, current and readily available when required.
Support the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products, including maintaining documentation relating to product origin and destination to support product safety, quality and efficacy.
Review and approve, as applicable, equipment qualification reports, audit trails and analytical method transfers in accordance with established procedures.
Assist in the management and maintenance of QP declarations and related quality documentation.
Manage and maintain the Site Approval, Product List and Approved Suppliers List, ensuring that all information remains accurate and up to date.
Prepare and maintain job descriptions relating to Quality Assurance personnel in collaboration with the relevant management.
Manage GMP training requirements and personnel training files, ensuring that required training is appropriately scheduled, completed, documented and maintained.
Ensure that any non-conformance relating to products, procedures or cGMP requirements is reported immediately to the QA Manager (Quality Systems) or Qualified Person (QP).
Promote and ensure a high standard of GMP compliance, housekeeping and hygiene throughout Pharmadox Healthcare premises.
Ensure that all quality-related documentation and records are completed accurately and within the required timeframe and submitted for the appropriate review and approval.
Coordinate and monitor the timely execution of temperature mapping activities across both Company sites and ensure that the relevant documentation and reports are appropriately maintained.
Support the QA Manager (Quality Systems) and QP with other Quality Assurance, Quality Management System and GMP-related activities as required.
Perform any other duties and responsibilities related to the position as reasonably assigned by management.

What We Offer

A professional and supportive working environment.
The opportunity to gain broad experience.
Opportunities for professional development and career growth.

Qualifications

B.Pharma or B.Sc degree or diploma in sciences or 2 years of work experience in the QA department.
Possession of interpersonal and general communication skills.
2 years of working experience in a GMP environment.

Quality Assurance Officer

Job Description