Max. € 80,000
Detachering via YER
Medical & Health
Over deze vacature
Responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
- Bachelor's degree. Preferably Information Technology, Engineering or equivalent
- Experience: Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations
- Experience in delivering validated IT solutions or an application support role
- Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations
- Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation/compliance
- Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment
- Limited supervision required in day-to-day activities
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.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to MSD.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
- This includes involvement in quality-related activities for computerized systems that are required by the Quality Manual or with potential for impact on product quality, patient safety or data integrity
- Will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement
- The Quality Specialist will be responsible for: Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work
- Providing the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations)
- Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans)
- Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective
- Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance
- Driving resolution of regulatory non-conformance for GMP computerized systems
- Monitoring and communicating system health, compliance and other metrics updates to key stakeholders
- Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices
- Representing QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues
- Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems