Internal Auditor

For our big pharmaceutical client in ZUCHWIL we are looking for an INTERNAL AUDITOR for a 6-MONTH contract.

DURATION: 01/06/2018 TILL 30/11/2018

LOCATION: ZUCHWIL

WORKLOAD: 100%

PRIMARY TASKS AND RESPONSIBILITIES:
- Conduction of internal audits according 21 CFR 820; ISO EN 13485:2016; MDD; other applicable regulations
- Writing of internal and reports and creation of relevant documentation
- Follow up of internal and external audit observation to assure appropriate and timely implementation of Corrective Actions
- Provide Regulatory Compliance support in all areas of Quality System Elements
- Documentation review in Quality System relevant areas

IDEAL FEATURES:
- Previous experience in a similar position in auditing in the medtech or pharma
- A qualification as an auditor within the medtech is highly appreciated and as well the training in the new ISO 13485:2016

NON-TECHNICAL PROFILE REQUIREMENTS:

- Accepts personal responsibility for client satisfaction;
- Strong tracking, coordination and project planning skills;
- Establishes and manages engagement objectives, expectations and quality plan;
- Ability to identify and implement process and/or application improvements;
- Strong analytical and problem-solving skills;
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management procedures and internal guidelines;

METHODOLOGY/CERTIFICATION REQUIREMENTS:

- Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred;
- Additional certification is a plus;

LANGUAGE PROFICIENCIES:

- English spoken and written;

For further details please contact Beata Arciszewska