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Haarlem, Noord-Holland, Nederland Teva Pharmaceuticals Voltijd{"title": "Manager Validation", "description": "The OpportunityAs a Manager of Validation and Calibration at Teva Pharmaceuticals, you will be responsible for the coordination of the validation of all systems and the calibration of equipment on our site. You will lead a team of 4 validation experts and 3 calibration engineers.This is a complex group of...
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Laboratory Equipment Validation Specialist
2 maanden geleden
About the Role
The Quality Analytical Laboratory plays a crucial role in conducting all necessary analytical evaluations to support the manufacturing of Cytotoxic and Inhalation pharmaceutical products. This laboratory is engaged in a diverse range of analytical testing protocols to assess Active Pharmaceutical Ingredients (APIs), excipients, packaging components, and finished drug products for both release and stability assessments. Additionally, the department is tasked with the transfer, validation, and verification of analytical methodologies for new drug product testing. A variety of analytical techniques are employed, including GC, UPLC/HPLC, FT-IR, and UV-VIS. To enhance and fortify this responsibility, we are seeking a dedicated Equipment Qualification Engineer.
Key Responsibilities
- Evaluate, qualify (including validation), and implement advanced high-end (computerized) laboratory instrumentation (such as GC, UPLC/HPLC, FT-IR, and UV-VIS).
- Establish priorities within your projects while monitoring project execution across various departments.
- Ensure the timely completion of all validation documentation, including the coordination of contractor activities.
- Communicate project status updates to stakeholders and senior management.
- Draft training manuals, calibration protocols, maintenance schedules, operational procedures, equipment specification documents, and reports (URS, Risk assessments, IQ/OQ/PQ).
Qualifications and Experience
- A minimum of a Bachelor’s degree in Chemistry or a related discipline.
- Strong organizational skills are inherent to your nature.
- Familiarity with scientific analytical methodologies.
- Comprehensive knowledge of laboratory equipment, with hands-on experience in calibration, qualification, and validation processes.
- A background in the Pharmaceutical sector or a comparable GMP environment for 4-5 years, including at least 1 year of experience in laboratory equipment validation.
- A collaborative team player with excellent communication skills and a proactive mindset.
- Proficiency in writing documentation in English is essential.
Pre-employment Screening
Teva Pharmaceuticals will conduct appropriate verification and legally permissible vetting prior to confirming any employment offer. Further details regarding this verification and vetting process will be provided if you progress to this stage of the application.
Contact Information
Ivo Huijskens - Senior Recruiter Europe
