Job Description & How to Apply Below
A Qualified Person is required by CareerWise Recruitment for an 18 month contract with our major, Cork basedROLE:
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
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.
B. Sc. in a relevant discipline.
Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
A number of years of relevant experience in the pharmaceutical industry
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.
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
Demonstrates working knowledge with good proficiency in Microsoft Office applications.
Knowledge of Six Sigma, Define-Measure-Analyse-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.
Less than 1 Year
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