MES Quality Assurance Specialist
We are seeking a highly skilled MES Quality Assurance Specialist to join our team. As a key member of our quality assurance group, you will be responsible for ensuring the quality and compliance requirements are fully embedded into the MES design, deployment, and usage.
Job Description:
* Solidify Quality and Compliance Requirements - Collaborate with the MES implementation teams (IT and MES COE) and business stakeholders to ensure quality requirements are well integrated into the MES application.
* Promote Standardization and Harmonization - Lead efforts to streamline, standardize, and harmonize production/quality-related processes, batch record structures, and documentation across all manufacturing sites using MES.
* Foster Cross-Site Alignment - Drive cross-site alignment on production/quality workflows, ensuring a unified approach to digital batch records and electronic quality management.
* Define Integration Roadmap - Define and develop the integration roadmap for quality testing equipment (e.g., LIMS, PAT, lab devices) with MES platforms.
* Ensure Regulatory Compliance - Collaborate with global and site teams to ensure regulatory compliance, including preparation and review of validation protocols, user requirement specifications (URS), and other quality documentation.
* Develop Regulatory and Validation Documentation - Contribute to the creation and maintenance of regulatory and validation documentation (CCR, MVP, CSV, IQ/OQ/PQ, etc.) as part of the global MES deployment strategy.
* Support Training and Communication Initiatives - Support change management, training, and communication initiatives to drive adoption and sustainment of MES quality standards.
Requirements:
* Quality Assurance Expertise - 5+ years of experience in quality assurance, MES implementation, or manufacturing systems in a regulated (GxP) environment.
* MES Platforms Experience - Proven experience in MES platforms (e.g., Werum PAS-X, Siemens Opcenter, etc.) and understanding of digital batch records.
* Strong Quality Management Skills - Strong knowledge of quality management systems, validation principles, and regulatory frameworks (e.g., FDA, EMA, GAMP 5).
* Cross-Functional Leadership Skills - Demonstrated ability to harmonize processes across global teams and translate business needs into technical requirements.
Benefits:
* Competitive Compensation Package - Competitive and attractive employee compensation package.
* Employee Benefits - Pension contributions, sick pay, health insurance, paid public holidays.