QA Manager

Desired Skills: quality assurance,GMP,regulatory inspections

The role:

PE Global are currently recruiting for a QA Systems & Compliance Technical Manager on behalf of a leading pharmaceutical company in Cork. This is an initial 12 month contract role.

Description:

The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Responsibilities:

• Act as a business process manager for applicable quality systems.
• Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
• Work with key stakeholders to identify and implement system improvements,
• Analyse performance through metrics and trending,
• Troubleshoot issues and support the business with queries,
• Benchmark leading practices & identify opportunities to enhance systems,
• Liaise with global colleagues to share learnings to ensure consistency across the network and alignment with global processes.
• Provide QA review and/or approval for Supplier Management and other Quality System activities impacting GxP operations, including (but not limited to):
  • Deviations
  • Changes
  • Specifications
  • Technical / Quality Agreements
• Provide additional support to Quality Systems and Compliance team:
  • Support audit and inspection activities for site, including preparation, participation, and follow up actions.
  • Lead activities associated with the site quality management review process.

Education & Experience:

• Bachelor’s degree in Pharmaceutical Sciences, Process Engineering or related discipline.
• 10–15+ years’ experience within GMP-regulated pharmaceutical or biotechnology environments
• 3-5 years in leadership roles, with experience in people management and a proven ability to influence cross-functional teams and stakeholders.
• Significant hands-on experience supporting regulatory inspections.
• Knowledge of EU GDP Guidelines and regional regulatory requirements.
• Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***