the quality department - Leading audit teams - Checking the production process to ensure compliance and regulatory guidelines REQUIREMENTS - BSc in bioprocesstechnology, biochemistry or related field - At least 5 years of experience in a pharmaceutical
technologische achtergrond kennis en ervaring met auditing binnen Food/Pharma. Minimaal 5 jaar relevante QA werkervaring binnen Food/Pharma. Een succesvol trackrecord in project management binnen Food Quality. Ervaring met kwaliteitssystemen zoals FSSC 22000 etc. Ervaring met productie van kindervoeding is een
- Generate, review and authorize Quality related documents; - Maintain the CAPA (Corrective and preventive actions) system; - Maintain the complaint handling system - Investigate deviations and NCR’s (non-conformances), by determining the root cause and implementing corrective and preventive action ...
of Quality processes, implementation of a Risk Evaluation program, perform external party audits an act as the representative in front of the Health Authorities. Within a matrix organization, this role involves the management of 6 direct reports and +50 indirect reports in several departments ...
department innovatively deliver expertise and quality. They offer general medical for various therapeutic areas. ROLE DESCRIPTION You will be part of a team of about a dozen QA professionals that supervise and maintain the quality management system
- Project management for a new software tool including rollout in area Quality Management RESPONSIBILITIES - Defining needs and strategy - Ensure compliance according GAMP5 and GxP - Document review and CSV - Budget control - Training of employees according
- Work independently as group advisor for quality specialists in the organisation. RESPONSIBILITIES - SOP, process development - Develop Quality Processes - Support the team, line managers, project managers and QC departments - Involved in QC checks of
improvement of the quality systems and processes (incl. CAPA, investigations, complaints etc.) Representing your business unit in global quality projects and ensure compliant, effective and efficient outcomes Preparation of management decisions according quality matters Providing site support through quality
comply to the quality management system. As well as creating quality function deliverables for the quality management system in projects, in life cycle management and in post market surveillance at their development site. RESPONSIBILITIES You will be deploying ...
in contact on a regular basis. You will safeguard the quality of the organization and will be an important point of contact concerning aspects such as inspections. Also, you will act as the backup QP, for which training will be provided if you do not possess this status yet ...
automated technology particularly 21 CFR and ISO 13485 - Preferred Qualifications: Engineering background. Prior group or team leadership experience. Procedural or Technical writing experience. Understanding of modeling tools. - Awareness of Project Management Institute standards. Are
registration... needs now to be updated and in compliance with the Serialization regulations, The job will require a close interaction with Supply Chain and packaging. RESPONSIBILITIES - Ensure all Quality aspects of the Serialization program - Coordination of the update
to retain compliance to applicable standards. As well as Facilitating development projects to achieve compliance. • Clarifying customer requirements for quality assurance • Risk assessment sessions • Prepare management review meetings • Develop and conduct training programs • Establish and maintain
with GMP - Performing quality assurance audits and inspections - Occasionally provide Compliance training REQUIREMENTS - BSc. in life science related field - Several years of experience in a pharmaceutical company - Knowledge of GMP and QMS - Fluent in English and
end date of this project is not yet known, expected 6-8 months. RESPONSIBILITIES Your other responsibilities are to optimize planning of manning and resources. You will assist the QA manager in validation activities and maintenance of validation documentation ...
Supervision over quality systems - IATF16949 Team Management Creating policy and standards into the overall quality management process, defining quality procedures Undertaking internal quality audits Representing company in front of major customers and suppliers Requirements: Minimum 3 years of
Quality Manager you support the Quality department with your knowledge and experiences. RESPONSIBILITIES - Qualification and audits of suppliers - Perform internal audits - Manage planning and follow up of the regular inspections and external audits performed