Overzicht
Serves as a quality advisor for investigators and recommends actions to ensure a state of continued compliance avoiding recurrence. Works with the site validation teams providing guidance in the strategy, planning, delivery and retirement of computerized systems, equipment, facilities and utilities qualification, among other systems. Reviews and approves cGMP documents associated to the project in compliance with site SOPs, Company Guidelines/ Procedures and federal as well as local agencies regulation supporting business goals. Ensures quality concerns and/or opportunities are presented to management and/or project teams for prompt resolution. Develops and delivers current Good Manufacturing Practices (cGMP) training to personnel in order to enhance the site level of compliance, according to site and industry compliance trends and needs
Approves investigations assuring they are complete, accurate, technically justified with the required documented evidence including risk assessments, robust remedial/corrective/preventive actions, trend analysis (per cause and products), as applicable. Investigations evaluation must be based on the nature of the process performing an in-depth and thorough evaluation resulting in an assertive fast decision, assuring a state of compliance. Manages, evaluates and approves changes assuring they are in compliance with applicable SOP’s, quality manual, products market filing, and qualification (as applicable) and are closed with all the supporting documentation. Ensures the update of all impacted documentation prior to the implementation of the change.
Tracks the overall status of all quality systems assigned (investigations, complains, CAPAs, APR, QMS changes, etc.) assuring completion with the due date. Generates APR, including comparison with previous year; graphical evaluation and statistical analysis. Participate in Quality Area projects to develop and implement improved/lean processes. Participates in the development/revision of company policies/guidelines/procedures and implementation in the site. Prepares and/or reviews performance metrics for quality systems (APRs, change control, complaints investigations and their CAPA systems) on a monthly basis. Present in the SQC as required. Acts as mentor/coach of the quality systems processes (minor deviation, complaints, change management, annual product reviews, etc.). Communicates any major or critical observations to management for proper immediate, interim and final action(s) to be taken to reach compliance. Evaluates any proposed changes to RC to assure sustainability.
In 1923, Saal van Zwanenberg started Organon, where at that time pancreatic porcine insulin was purified. It was the start of over 90 years of innovative pharmaceutical production in Oss. Approximately 1,500 colleagues currently work on the production and development of medicines at two locations.
Quality Operations (QO) at MSD Biotechnology operations Oss has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensures adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.
Provides day to day support for Biotech Operations, raising concerns if needed or directing users to do so. In co-operation with functional areas and in line with quality procedures and guidelines, support the handling of deviations, including implementation of CAPA’s. Partner with internal and global groups for technical issues resolution related to investigations or system issues.
Responsible for the management and continuous improvement of the change control, complaints, annual product review (APR), quality management, CAPA and deviations systems, Environmental Monitoring. Responsible for the evaluation and approval of the investigation reports (both complaints and deviations) to ensure adequacy, compliance with cGMP requirements and quality of the investigations. Works in the implementation of other continuous improvement, Lean and Operational Excellence initiatives.- Knowledge of and experience with quality and compliance guidelines and manufacturing processes
- Knowledge of regulations in production, validation, quality assurance/control, quality systems (investigations, change controls, etc.)
- Ability to convert quality mindset into practice and to bring others on that same page
- Computer literacy knowledge
- Statistical knowledge
- Strong focus on clients
- Ability to work under minimum supervision
- Team work oriented
- Strong communication skills, oral and written (in Dutch and English)
- At least >5 years of experience in the pharmaceutical industry within the quality operations department
Vacature type:
Categorie: Engineering
Ervaring: Full-time