Qualification Engineer
eTeam
Datum: 1 week geleden
Stad: Haarlem, Noord-Holland
Contract type: Voltijd
Client
The Client is a multinational pharmaceutical company, specialized in generic drugs and pharmaceutical ingredients.
Summary
The Quality Analytical Laboratory is responsible for all analytical testing to support the production of Cytotoxic and Inhalation drug products. The laboratory executes a wide variety of analytical test packages to test APIs, excipients, packaging materials and drug products for release and stability purposes. The department is also responsible for transfer, validation and verification of analytical methods for testing of new drug products. A variety of analytical techniques is used a.o. GC, UPLC/HPLC, FT-IR and UV-VIS. In order to expand and strengthen this responsibility, the Quality Analytical Laboratory is searching for an Equipment Qualification Engineer I.
Main Responsibilities
The Client is a multinational pharmaceutical company, specialized in generic drugs and pharmaceutical ingredients.
Summary
The Quality Analytical Laboratory is responsible for all analytical testing to support the production of Cytotoxic and Inhalation drug products. The laboratory executes a wide variety of analytical test packages to test APIs, excipients, packaging materials and drug products for release and stability purposes. The department is also responsible for transfer, validation and verification of analytical methods for testing of new drug products. A variety of analytical techniques is used a.o. GC, UPLC/HPLC, FT-IR and UV-VIS. In order to expand and strengthen this responsibility, the Quality Analytical Laboratory is searching for an Equipment Qualification Engineer I.
Main Responsibilities
- Assessing, qualification (incl. validation) and implementation of sophisticated high-end (computerized) Laboratory equipment (such as GC, UPLC/HPLC, FT-IR and UV-VIS),
- Determine priorities within own project, while keeping track of project execution across multiple departments,
- Oversees the timely completion of all validation documentation, including coordination of contractor activities,
- Present project status to stakeholders and (senior) management,
- Write training instructions, calibration, maintenance, operational procedures, equipment specification files and reports (URS, Risk assessments, IQ/OQ/PQ).
- A minimum of HBO in chemistry or related field,
- Organizational capabilities is part of your nature,
- Experience with scientific analytical approaches,
- Good knowledge of laboratory equipment with experience in calibration, qualification and validation,
- Experience in the Pharmaceutical industry or an equivalent GMP environment for 4-5 years with at least 1 year experience on validation of laboratory equipment,
- Team player with sound communication skills and pro-active approach,
- Experience with writing documents in English is required.
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