Our client, a pharmaceuticals company based in Ireland, now has approval for the new role of Principal Quality Auditor for their broad product portfolio, including marketed drug products and some generic products. The remit of this role is across Europe and Middle East geographical regions. This role is approved at Principal level and will report to the Senior Quality Auditing Manager.
As a Quality Assurance Subject Matter, the successful candidate will exercise their QA oversight and auditing expertise in across internal (the company's business units and internal manufacturing sites) and external network (supplier, vendors, CMOs, etc.) ensuring products, controls, policies and processes meet Pharmaceutical/Biotechnology industry quality standards.
The ideal candidate will have extensive Quality Assurance experience across operations and/or laboratories, covering some of the following: Analytical, Quality Control, Microbiology, Sterile Drug Product, Contract Packaging, Mock Pre-approval inspections, internal corporate audits, etc.
- Leads Pre-Approval Mock Inspections to prepare CMO facilities for regulatory inspections and assesses gaps in the quality systems and overall infrastructure.
- Manages the auditing metrics program which involves tracking audit responses and auditee’s CAPAs until completion and closeout.
- Manages audit activities which include audit agendas, audit reports and communicates finding to external and internal stakeholders.
- Performs evaluations of quality systems and practices to identify potential problems such as non-conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels
- Leads or provides guidance for cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards.
- Evaluates metrics to determine trends and opportunities for continuous improvements.
- Assists in FDA inspections and may interact with regulatory authorities during regulatory inspections.
- Bachelors’ Degree in Science or similar discipline, with a minimum of 10 years’ Quality Assurance experience in a pharmaceutical, medical devices, diagnostics manufacturing environment.
- ASQ-CQA or ASQ-CQE certified highly desired.
- Proven QA expertise with standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines and guidance docs) and application to products pending release, and marketed products.
- Experienced in investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents
- Proven expertise in conducting GMP audits of drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials and packaging components.
- Proven ability to conduct focused quality incident investigations.
- Effective communication and relationships management skills, with internal and external customers to achieve company goals.
- Proficiency with MS Office Suite including MS Word, MS Excel and MS PowerPoint, is required.
Please phone Larry on +353 (0)1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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