Qualified Person QP

  • Job type

  • Location

  • Specialism

    Quality Assurance
  • Industry

  • Pay


Qualified Person, QP, Quality Assurance, Pharma

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:

  • 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

Talk to Emma Davidson, the specialist consultant managing this position

Located in Hays Recruitment, Cork, 54 South Mall, CorkTelephone:+35315827794
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