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Quality Control Lead

  • GE Healthcare
  • Experienced
  • Posted 11/20/2017 4:52:08 AM
  • 3027518
  • Job Function: Manufacturing
  • Business Segment: Healthcare Quality
Location(s): Netherlands; Eindhoven

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Role Summary:
The Quality Control (QC) lead provides leadership to part of the Quality Control team of our radiopharmaceutical manufacturing site. The QC team executes and supports validation and (improvement) project activities. The leadership of the QC team is divided over two Quality Control leads. In this function the Quality Control Lead is responsible for the organization of the testing of our materials/products and leading part of the team.

Essential Responsibilities:
Key responsibilities include:

  • Providing leadership and coaching for the Quality Control team
  • Ensuring the timeliness and compliant testing of raw materials, intermediates and final drug products in our just-in-time process following GMP guidelines
  • The production takes place during the day, evening and night
  • The position will focus on product quality through testing, data analysis and issue resolution
  • Coaching the Quality Control team (7 to 10 employees) on the tools and practices required to drive day-to-day processes
  • Participating and leading qualification and validation of Quality Control equipment and processes
  • Assist in troubleshooting instrumentation issues
  • Identifying and initiating improvements in the quality of QC processes and methods
  • Participating in the plant-wide effort to reduce scrap and rework costs, and to identifying root causes and solutions for quality defects
  • Ensure the meaningful and timely resolution of IR’s, CAPA’s, complaints and change controls
  • Reviewing and approving QC related deviations, Out of Specification (OOS) investigations, Change Controls, CAPAs, procedures, specifications and reports
  • Developing and maintaining quality control documents
  • Working in close collaboration with other QC lead

Quality specific goals:
  • Knowledge and understanding of Quality Control process work instructions and operates within them to ensure that all our radiopharmaceuticals conform to
    their specifications
  • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and
    regulations as they apply to this job type/position
  • Complete all planned Quality & Compliance training within the defined deadlines
  • Identify and report any quality or compliance concerns and take immediate corrective action as required
  • Develop an open quality culture within the organization that fosters issue discussion and decision-making based on quality and compliance objectives
  • Ensures the creation of accurate, complete and timely records

  • Minimum Bachelor’s degree in Life Sciences such as Pharmaceutical Sciences, (Bio)Chemistry, Analytical Chemistry plus significant working experience and
    knowledge of quality control
  • Demonstrated knowledge and experience in a variety of QC methods and related software (Chromatography (HPLC, TLC), gamma spectrometry, wet chemistry
  • Demonstrated effective interpersonal, teamwork, networking skills, collaboration, negotiation & conflict resolution skills
  • Demonstrated ability to lead and develop a team
  • Proven managerial/leadership skills such as work planning & evaluating
  • Process improvement experience, knowledge of continuous improvement methodologies & in-depth understanding of related processes
  • Ability to make decisions under pressure and take ownership for assigned projects and programs
  • Analytical, problem solving & root-cause analysis skills
  • Ability to handle multiple tasks with competing priorities effectively
  • Strong communication skills in English and Dutch (verbal & written)
  • Ability to interface and influence at all levels in the organization
  • Strong organizational skills
  • Working knowledge of Word, Excel, PowerPoint
  • Knowledge and experience in validation and qualification processes

Desired Characteristics:
Preferred qualifications:
  • Demonstrated experience & knowledge with regulations in the pharmaceutical industries (GMP)
  • Change agent with energy, passion & enthusiasm to drive change
  • Demonstrated experience in project/risk management
  • Knowledge in working with radioactivity
  • Knowledge in radiochemistry
  • Demonstrated experience in data analysis, statistics and maintaining (electronic) data
  • Experience in LIMS or equivalent laboratory information management systems
  • Knowledge of sterile product manufacturing

Locations: Netherlands; Eindhoven

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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