QA for ENG

QA for ENG

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

The QA for ENG sits within the German Quality organization and will be responsible for the QA management on qualification and validation activities for facilities utilities equipment computerized systems cleaning process in Wuppertal (MFG19) and Aprath Lab to ensure the compliance.

Department Description

As QA for ENG you will be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing lives. In this role you will report to the QA Ops Team Lead.

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

• Be responsible for WTST Engineering Onsite GMP management.
• Be responsible for the related deviation validation variation change control CAPAs review and approval and relevant effectiveness check with regard to engineering field.
• Participate the client/regulatory audit communication and technical response with regard to engineering.
• Continuously improve the equipment calibration/preventive maintenance management.
• Participate the engineer equipment qualification and revalidation/re-evaluation activities.
• Involved in URS creation; review and approval.
• Involved in design documents: Functional Design Specification Configuration Specification (embedded systems).
• Review and approval for Qualification Protocols and executed protocols reports.
• Perform additional duties at the request of direct supervisor.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications/Experience:

• A Bachelors degree in a technical discipline would be an advantage.
• At least 5 years of relevant working experience in the pharmaceutical industry with at least 3 years spent in a Quality role.

• Strong oral and writing English (Chinese and German is a plus).
• Solid understanding of GMP and European regulations (German drug law is a plus).
• Results oriented and ability to deliver under pressure in a fast-paced environment.

• Think individually with a strong sense of service decisiveness and responsibility. Good knowledge of Microsoft Office PowerPoint Word Excel.

Besondere Kenntnisse / Special Knowledge

• Good organizational skills.
• Good interpersonal communication skills.
• Excellent oral & written communication skills (English; German is preferable).

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

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WuXi Biologics is an equal opportunities employer.