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Qualified Person (QP), Cork



Cork, Ireland 

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€0.00 - €0.00

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Job Description:

Qualified Person (QP) – 12 Month Contract

Specific Responsibilities:

* Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
Certifies batches for sale or supply in compliance with regulations.
* Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
* Attends and participates Event Review, Quality Systems Review and Site QP Meetings
* Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
* Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
* Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
* Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
* Works 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.

Knowledge, Experience and Skills:

* Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

* Proficient in application of QA principles, concepts, industry practices, and standards.
* Demonstrates ability to effectively manage multiple projects/priorities.
* Proven analytical and conceptual skills.
* Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
* Demonstrates excellent verbal communication, technical writing and interpersonal skills.
* Demonstrates working knowledge with good proficiency in Microsoft Office applications.
* Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
* Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (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 QP on a manufacturing license preferable
* Some years of relevant experience in the pharmaceutical industry and a BS or BA.
Company Info
Berkley Recruitment Group
Mill House, Carrigrohane, Cork T12 C672
Cork, Ireland
Phone: 00353214289600
Web Site: www.berkley-group.com
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