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.
- 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
- 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.
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The Life Science Specialists