QA Manager

  • Cork
  • Permanent
  • JO-1706-62615_1498045452

Summary

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

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