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  • Quality Assurance Specialist - Pharmaceutical Paris
  • Chikara HR in Paris, , France
  • jobs
  • 1 week ago

jobs description

• Exciting new role with growing start-up research organisation!
• Opportunity to impact the quality of an innovative clinical study
• Eastern Yvelines location, on site

Are you a Quality Assurance Specialist looking to work directly with a sponsor? My client is searching for a confident and autonomous Quality professional to manage operational aspects of their quality systems.

Key Responsibilities:

Implementing and monitoring the quality system
• Implementing the quality system, developing and updating systems and tools: organisational methods, operating modes, processes, procedures, indicators, checklists, information media, audits, training, etc;
• Drafting and monitoring the application of quality procedures;
• Checking compliance with the defined quality system, and the consistency of quality procedures and applicable regulations in relation to the company's activity;
• Monitoring deviations, proposing and monitoring the implementation of quality, preventive or corrective... actions (CAPAs);
• Steering risk analyses and change controls
• Monitoring quality dashboard indicators and systematically alerting the company to any anomalies;
• Updating and continuous improvement of the company's quality management system, including the development of new quality indicators.
• Carrying out the quality review of documents relating to clinical trials.

Product QA
• Evaluating the criticality of investigation reports on OOT/OOS results, anomalies, non-conformities, deviations and complaints.
• Participation in monitoring the pharmaceutical quality of products developed
• Helping to check batch conformity
• Ensures compliance of distribution to the investigating centre(s)

Supplier QA
• Participates in the drafting and review of supplier specifications
• Evaluating the company's suppliers and service providers
• Management of supplier deviations.

Audits and inspections
• Planning and carrying out self-inspections/internal audits
• Participating in supplier and service provider audits
• Maintaining and monitoring the audit schedule
• Participating in preparations for audits and inspections carried out by the authorities

Information, advice and training
• Alerting the Quality Assurance Manager in the event of a critical event
• Participates in relations with health authorities
• Monitoring regulations relating to good practice (GCP, GMP, GLP, BPD, etc.), quality standards applicable to the site and guidelines/ICH.
• Raising quality awareness and training the departments concerned
• Participation in training activities relating to GCP in particular
• Answering internal and external questions about quality

About you:
• Minimum 3 years' higher education in Quality
• At least 2 years industry/post graduation experience in pharmaceutical quality assurance in a similar position
• Confident in knowledge of QA systems and able to work with limited supervision
• Experienced in project managing QA operations and working cross functionally
• Comfortable working from the eastern Yvelines site on a daily basis
• Fluency in both French and English is an essential requirement of the job
• Right to work in France, visa sponsorship is not possible

By applying for this position, you confirm that you are comfortable for your information to be stored and processed by Chikara HR as part of this recruitment. Next steps will always be discussed with you in advance
Paris France

salary-criteria

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