Pharmaceutical Equipment Qualification Compliance

2 giorni fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**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:

- 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 years of experience in **pharmaceutical industry** **and in validation field
- this is a must**
- good knowledge of Italian and English language (level B2) written and spoken

We offer chemical pharmaceutical permanent contract + benefits.

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