Qualified Person

Location: Cork, Dublin
Posted On: 8/9/2017
Job Code: Qualified Person
Job Description
• 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).
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
Category:Non-IT  code:new
Job Requirements
• candidates ideally should possess solid oral dosage and sterile experience.
• candidates should have worked on a licence previously
• 2nd packaging experience desirable.
• 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 MS 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.
• 7+ years of relevant experience in the pharmaceutical industry and a BS or BA.
• 5+ years of relevant experience and a MS.
• Academic Level : Bachelors

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Contact Details
Arti Tripathi
E-mail Address