The Manager QC Systems and Support provides direct management to Technicians, Associates and Specialists, overseeing daily activities, ensuring safety, quality, and performance targets are achieved, and leading continuous improvement of Quality Control systems.
Locations (2)
Leiden, Netherlands, Netherlands
Utrecht, Netherlands, Netherlands
Responsibilities
Provide direct management of the QC Systems and Support team and oversee daily activities
Develop and execute a work plan for the team, ensuring safety, quality, and performance targets are achieved
Track, trend, and report key performance metrics
Author, review and approve records and technical documents ensuring compliance
Own and evaluate relevant change controls, investigations, deviations and CAPAs
Requirements
Bachelor's degree or equivalent, preferably in science
The Master Data Specialist is accountable for the management, integrity, and optimization of master data within QC, such as but not limited to the Laboratory Information Management System (LIMS). This role requires collaboration with various stakeholders to ensure data accuracy, accessibility, and compliance with regulatory standards.
Responsibilities
Maintain and manage master data, ensuring accuracy, consistency, and compliance with GMP standards.
Work with stakeholders to define data requirements and contribute to data governance initiatives.
Engage in projects and initiatives, providing input for the implementation of new functionalities or enhancements based on business needs.
Create, review, and update relevant documentation, including SOPs and data management policies, ensuring clarity and compliance.
Lead data integrity assessments and implement initiatives related to master data management.
Requirements
Bachelor’s degree (or equivalent) in a relevant discipline
To support the R&D Department in maintaining accurate, complete, controlled, and compliant documentation related to pharmaceutical development activities, ensuring documents are prepared, reviewed, issued, archived, and retrieved in accordance with GMP, company procedures, and applicable regulatory requirements.
Responsibilities
Prepare, organize, update, and maintain R&D technical documents, records, reports, protocols, and related forms.
Ensure proper document numbering, version control, filing, distribution, and archiving in accordance with approved procedures.
Maintain accurate and traceable R&D records and ensure completeness and integrity of documented information.
Coordinate document review and approval cycles with R&D team members and relevant stakeholders.
Support documentation activities related to changes, revisions, and updates to R&D documents.
A corporate quality position responsible for strengthening the effectiveness of cGMP training across Sharp’s global network, focusing on shop floor and operational training in manufacturing, packaging, labeling, laboratory, and warehousing.
Responsibilities
Assess the current state of GMP training at Sharp, with specific emphasis on shop floor, operational, and laboratory roles.
Identify specific, high-impact gaps where improved training will meaningfully reduce deviations, right-first-time errors, rework, and inspection risk.
Establish a focused, phased improvement roadmap that prioritizes GMP activities related to critical roles and high-risk processes.
Define which elements of key roles require structured, formalized On-the-Job Training (OJT).
Technical leadership and hands-on support for environmental monitoring (EM) programs and microbiological sampling activities across manufacturing operations.
Compensation
The typical hiring range for this position is $72,720-$90,900. The base pay offered may vary depending on job-related knowledge, skills, experience, education, and internal equity. In addition to base salary, this role may qualify for an annual bonus based on employment type.
Responsibilities
Serve as the site subject matter expert for Environmental Monitoring (EM) programs and microbiological control activities.
Coordinate and execute environmental monitoring sampling activities in manufacturing, packaging, laboratory, warehouse, and support areas.
Perform viable air, surface, personnel, and other microbiological sampling using qualified equipment and approved techniques.
Support EM program improvements, EMPQ activities, remediation projects, risk assessments, and implementation plans.
Monitor, review, trend, and analyze environmental monitoring data to identify adverse trends and potential contamination risks.
Requirements
College diploma or university degree in Microbiology, Biology, Biotechnology, or a related life science discipline
Nice to have: EM program implementation or remediation projects
Nice to have: EMPQ execution
Nice to have: Risk assessments
Nice to have: Data trending and analysis
Skills
Químico Analista de Soporte Analítico (Posicion Temporal - 12 meses)
Support the planning and execution of analytical method validation activities for chemical and physicochemical methods in accordance with approved protocols.
Responsibilities
Support the planning and execution of analytical method validation activities for chemical and physicochemical methods in accordance with approved protocols.
Prepare and organize samples, standards, reagents, solutions, reference materials, and documentation required for validation studies.
Execute validation tests such as specificity, accuracy, precision, linearity, range, robustness, system suitability, detection limit, quantitation limit, and method equivalency, as applicable.
Ensure training records reflect current qualification to perform validation, verification, and routine analytical method activities.
Verify instrument readiness, calibration status, analytical conditions, and system suitability requirements before executing validation or verification testing.
Supply Chain Coordinator ensures operational readiness for clinical packaging and supply activities by managing SAP master data, orders, and logistics to support clinical supply execution.
Compensation
The anticipated base pay range for this position is: €61,200.00 - €98,210.00
Responsibilities
Create and manage sales and purchase orders in SAP for relevant pack types, packaging campaigns and supply activities
Create and follow up stability orders and the related logistics activities
Provide proactive input to operational planning and follow up delayed deliveries or activities that may affect packaging or supply execution
Follow up assigned deliverables and milestones in the Milestone Planning Tool (MPT)
Participate in weekly reliability meetings with internal stakeholders and alignment meetings with P&L vendors
Requirements
Bachelor degree in a relevant discipline or equivalent relevant experience in supply chain, logistics, operations or a regulated life-sciences environment
Provide strategic, scientific, and operational leadership for GMP analytical technical operations supporting manufacturing, in-process and final product testing, analytical method lifecycle management, and clinical and commercial laboratory readiness.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $135,463.20 to $203,194.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement
Establish technical strategies for analytical readiness, including laboratory capability, instrumentation, materials, reference standards, reagents, methods, documentation, data systems, training, and external laboratory support
Provide technical oversight and scientific direction for complex laboratory investigations, out-of-specification and out-of-trend results, method-related deviations, and analytical risk assessments
Support quality records associated with analytical method lifecycle management, including deviations, CAPAs, change controls, and risk assessments
Serve as a key analytical technical interface across Quality Control functions, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and site and network partners
Join the Quality Control team in Cergy to ensure that materials and products under quality control meet defined requirements before compliant release for production or use.
Responsibilities
Perform assigned quality control tests applying approved methods and specifications to prevent the use or continued processing of non-conforming materials or products
Contribute to release decisions by reviewing quality control results and records against defined requirements and reporting identified deviations
Document quality control activities and results completely and accurately, in accordance with GMP, GLP, and data integrity requirements
Ensure the proper operation of quality control activities by checking assigned equipment, identifying supply needs, and initiating or flagging replenishment needs
Contribute to solving quality issues and implementing approved changes by performing assigned tasks related to deviations, investigations, procedures, projects, and improvement actions
Microbiology Specialist (Environmental Monitoring & Sampling) - 24 month contractTeva Pharmaceuticals · Scarborough, Canada