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CQV Engineer

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The company

Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands. This client is an international pharmaceutical organization, specialized in the packaging and distribution of medicines with a powerful sense of shared purpose toward their mission: to serve patients.

Role description

The CQV Engineer will demonstrate hands on commissioning/qualification skills, including but not limited to the following: develop, implement and report test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures. The CQV Engineer will drive the development of system commissioning qualification and validation documentation.

Responsibilities

- Documentation:
- Develop and Update several Validation documents, e.g. System Level Criticality Assessments;
- Commissioning, Qualification and Validation plans;
- Risk assessments;
- Protocols and reports;
- Requirement traceability matrices;
- Commissioning, Qualification and Validation summary reports.

- Testing:
- Lead Commissioning activities, Qualification activities and Validation activities;

- Technical support
- Deliver guidance to the project group, so the implement technical solution follows the validation plan in order to achieve meeting internal customer requirements, and accordance with our clients' SOPS;

- Any other tasks/projects assigned as per supervisor request.

Requirements

- Experienced with Secondary Packaging Systems, including experience with Print and Inspection systems (e.g. Systech, Cognex);
- At least 5 years’ experience in executing Commissioning, Qualification and Validation within manufacturing organizations in the pharmaceutical industries;
- Experienced in Computerized Systems Validation;
- Basic knowledge of Paperless validation systems (HP ALM/ KNEAT);
- Hands on commissioning and qualification experience within Secondary Packaging Operations;
- Good understanding of the role of a single document within the bigger picture;
- Internal and /or external reporting relationships.

Other information

- Ability to work independently and remotely with minimum direct supervision;
- Good English Technical Writing skills;
- Customer relationship management skills;
- Critical thinking skills;
- Able to set clear priorities and escalate to ensure timely delivery of the project phases including design, development, implementation, testing, construction, commissioning, and validation;
- Experience within a GMP compliance environment regarding practices, policies, procedures, legal requirements and goals of project, develop supporting documentation and monitor activity timeliness / scheduling;
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business expertise;
- Projectbased with expected end date of mid May 2020;
- Fulltime position on site.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michelle Tang.


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SIRE Information Technology®

Ref. number: 48855
Listed by: SIRE Information Technology®
Listed on: 08-10-2019
Country: The Netherlands
Region: Noord-Brabant
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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