Qualified Person

Proclinical is seeking a dedicated Quality Assurance Qualified Person.
This role will be part of a collaborative and innovative environment focused on delivering life-changing therapies to patients.
The successful candidate will contribute directly to the impact that rapid delivery of safe and effective treatments has and will ensure the compliance with regulatory requirements and quality standards.Responsibilities:Certify batches for sale or supply in compliance with EC directives.Release Investigational Medicinal Products in accordance with Annex 13 requirements.Approve Annual Product Quality Reviews, SOPs, complaint investigations, and deviations.Participate in Event Review, Quality Systems Review, and Site QP Meetings.Ensure compliance with quality objectives and regulatory requirements.Suggest changes to controlled documents to meet quality objectives.Maintain programs to ensure high-quality products and compliance with GMPs and GLPs.Review manufacturing, environmental monitoring, and quality control data.Conduct inspections, statistical process control analyses, and audits.Write annual product reviews and develop training programs.Lead or coordinate investigations and CAPA recommendations.Collaborate with R&D during new product start-ups and establish key checkpoints.Assist or lead compliance audits and interface with regulatory agencies as needed.Address documentation and compliance issues with contract manufacturers.Key Skills and Requirements:Relevant experience in the pharmaceutical industry and a BS or BA, or relevant experience and an MS.Proficient in QA principles, concepts, industry practices and standards.Knowledge on quality systems regulations.Excellent verbal communication, technical writing and the ability to be interpersonal.Proficiency in Microsoft Office applications.Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC.Knowledge of risk management tools is beneficial.Familiarity with Six Sigma, DMAIC methodology, performance measures, and quality improvement statistics is beneficial.