QA Systems Specialist

The QA Systems Specialist actively contribute to continuous improvement plan:

Provide QA support for:

• Investigation and closure for the Deviation and the Out Of Specifications
• Change Control and CAPA: initiation, implementation, coordination, follow up, closure
• Procedures writing in accordance with the cGMP and Policies
• Support the quality organization in the supplier qualifications activities through audit and follow up of CAPA plan.
• QA KPI follow-up.
• Work with relevant departments to ensure timely closure of quality actions and resolve compliance issue
• Performing internal audits
• Supporting the quality organization in the organization and accommodation of external audits (from customer and authorities).

• You have an Engineering or Chemistry degree
• you have min.3 years experience in a QA position
• You have very good knowledge of GxP in a regulated environment
• You have knowledge of risk assessment / validation /quality systems
• You have an excellent accuracy and attention to detail
• You have an excellent interpersonal skills
• You have strong problems solving skills, issue resolution and root cause analysis skills
• You are highly Flexible and Adaptable. You are able to work independently in a fast paced multitasking environment
• You have working knowledge of computer packages
• knowledge of Quality Software Systems (Trackwise, Lab software,…) is an asset
• You are fluent in English and French

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