Equipment Qualification Compliance Specialist
4 settimane fa
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing productivity in their laboratories, we are here to support them. Our distributed team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit
Main responsibilities of Equipment Qualification Compliance Specialist:
- Collaborate with Technical Services to ensure that equipment validation and calibration activities meets cGMP and Corporate Standards over the life cycle. Ensure that any planned changes to the facilities, equipment and utilities, which may affect the quality of the product, are formally documented and the impact on the validated status or control strategy is assessed.
- Promote proper and proactive business partnership with Technical Services Qualification and Calibration system Support Technical Services Group to ensure that:
- Decisions on the scope and extend of qualification are based on a justified rationale and, if necessary, on risk assessment of the facilities, equipment, utilities and processes;
- All documents generated during qualification and calibration are approved and authorized by appropriate personnel as defined in the pharmaceutical quality system;
- All qualification and calibration activities are planned and take the life cycle of facilities, equipment, utilities, process and product into consideration.
- Qualification and Calibration activities to ensure that:
- Qualification and calibration activities are only performed by suitably trained personnel who follow approved procedures and apply good documentation practices, ensuring the integrity of all data;
- Proper planning of qualification activities is respected by attending project plan meetings and sharing needs and expectations for full compliance;
- Change control and deviation management for qualification and calibration is performed according to cGMP and Corporate Standards;
- Support the relevant departments to ensure that the specification for equipment, facilities, utilities or systems are defined in a URS and/or a functional specification;
- If needed, participate to Factory acceptance testing /Site acceptance testing/ Design Qualification/ Installation Qualification/ Operational Qualification /Performance Qualification activities.
Requirements:
- CTF/Pharma degree
- 2/3 proven experience in pharma industry and in validation field
- Previous experience in CSV is highly preferred
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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