QA Manager

Fastnet The Talent Group

Cork

Reporting to the QA Director, the QA Manager will: Promote Quality Culture on site. Assure that medicinal products, investigational medicinal products, associated intermediates and APIs manufactured by the company are in compliance with EU GMP (as per EU Directives 2001/83/EC, 2001/82/EC, 2001/20/EC), and the relevant marketing authorization/ product specification file prior to batch certification for release. Coordinate with the QA Director and QP(s) in any required communications with the Health Products Regulatory Authority (HPRA) and customers. Responsibilities. To co-ordinate the approval and release of medicinal products, investigational medicinal products, APIs/ intermediates manufactured, in order to assure that current Good Manufacturing Practices and provisions of the marketing authorisation/ product specification file are applied. To ensure that the site marketing authorisation (MA) and ASR are updated as required. To communicate regulatory requirements to the different areas of the company as required. To assure that change control procedures consider regulatory filing implications, especially for critical changes requiring pre-approval, and to inform clients as required. Participate in cross functional investigations of deviations and change controls and advise on corrective actions and assist with their implementation as appropriate; Ensure the site Internal Audit Schedule is maintained; Foster an environment of Continuous Quality Improvement by identifying and implementing practices to deliver, quality, efficiency and service level improvements; Act a key contact for customer and regulatory audits. Prepare audit inspection reports, responses and liaise with Regulatory Authorities and Corporate Regulatory Affairs as required; Carry out audits of contract facilities/suppliers as required; Manage the group of QA direct reports, coaching and developing your team to ensure the highest quality service is delivered. Manage and deliver all QA activities related to Process support, Process validation, Cleaning validation, change control and deviation management on site. Enhance and maintain a strong robust Quality culture. Development and implementation of QA specialist activities. Ensure all inspection and audit activities are supported in a professional and efficient manner. Manage the Product Quality Review (PQR) process. Ensure the site meets all appropriate Quality Standards. Support review and release of manufactured batches as required. Technical support for clients and their products. Promotion of Quality, Safety and Right First Time Culture on site. Take a lead role in customer audits and Regulatory Inspections. Perform external auditing and liaison with Corporate Purchasing. Coordinate and perform Internal audits as required per Internal audit schedule. Requirements. University degree in Chemistry, Pharmaceutical Science or related field. 10 years' experience in the Pharmaceutical Industry. A proven track record of people management. In depth knowledge of cGMPs, ICH guidelines, EU Guidelines, CFRs. Excellent interpersonal skills with good leadership abilities. Experience as a lead internal auditor. Eligibility to act as Qualified Person is an advantage. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2254 days ago