Your new company
Here at Hays, we are looking for an experienced Qualified Person for our growing International Client in their Cork Manufacturing facility.

Our client is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need.

The company’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions

Reason for role: Expanding the department

Your new role:
Based in the Quality Assurance Department.

Essential Duties and Job Functions:

• Conduct responsibilities of QP stated in directives issued by EC.
• Certify batches for sale or supply in compliance with regulations.
• Approve Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
• Attend and participate in Event Review, Quality Systems Review and Site QP Meetings.
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Participate in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
• Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Review manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Work closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis to enforce requirements and meet specifications.
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.
• May assist or lead compliance audits as required.
• May interface with regulatory agencies as required. Interfaces with contract manufacturers to address documentation and compliance issues.

What you'll need to succeed:

Necessary:

• Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
• Relevant experience in the pharmaceutical industry.
• QP Manufacturing Licence

Professional Attributes:

• Resilient profile with the ability to deliver in an ambiguous environment
• Ability to engage and manage multiple stakeholders to achieve the objective
• Curious with learning agility
• Operationally excellent
• Organised with systematic approach to prioritisation
• Process orientated to achieve the business objective

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1102244