Qualified Person (QP)

Job Description

I have a really exciting opportunity that has just come available for a Qualified Person (QP) to work with one of Ireland's top biopharmaceutical companies in Cork on an initial 12 month contract.

To be considered for this role, you will need to currently be on a QP license or have previous experience on a license. This role is an hourly rate contract and will require you to be primarily fully on-site.

Job Responsibilities:

• Certify batches for sale or supply in compliance with regulations.
• Approving APQRs, SOPs, Complaint investigations, & Deviations.
• Attend and participate in Quality Systems Reviews and Site Meetings.
• Performs activities ensuring compliance with quality objectives and regulatory requirements.
• Writing controlled documents as needed to ensure defined quality objectives are met.
• Maintain programs and processes ensuring high quality products and compliance with current GMPs & GLPs.
• Reviewing the manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Cooperate with operating entities to ensure inspections, statistical process control analyses and internal and external audits are conducted on a continuing basis to enforce requirements and meet specifications.
• Participate in writing of the annual product reviews regarding all aspects of producing quality products.
• Lead investigations and CAPAs related to manufactured products.
• Cooperate in new product start-ups, and establishes key checkpoints for new products and processes.

Required Knowledge, Experience and Skills:

• Proficient in GMPs and/or GLPs.
• Understanding of international quality systems regulations to adopt best in class systems/processes.
• Working knowledge of risk management tools (HACCP) and / or FMEA is beneficial.
• Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
• Must be QP qualified.
• Current or Previous experience as a QP on a manufacturing license.
• 3+ years experience in a biological release or packaging experience.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.