Beschreibung
Für unseren Kunden in Österreich suchen wir einen freiberuflichenQualification and Validation Engineer (m/w)
Validation Engineer to provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements Validation Policies and Procedures are addressed.
Responsibilites:
- Managing Complexity/Technical Accountability ?
- Serve as technical expert for the Validation process and responsibilities to ensure compliance ?
- Continuous Learning/Managing Risk ?
- Resolve & manage technical operational problems in area of expertise ?
- Suggest and sometimes may implement innovation and continuous improvement within the
Validation process ?
- Implement initiatives in the Validation Process that will deliver customer value at lowest cost. ?
- Facilitate successful team behavior within Quality Systems and across functional areas ?
- Manage relationships externally and internally. ?
- Build cross-functional and cross-departmental support, fostering overall effectiveness ?
- Foster harmony within Quality Systems. ?
- Influence and persuade so as to bring about technical and process improvements. ?
- Ensure accuracy and maintenance of the Validation Master List. ?
- Review and approve Validation Master Plans, Protocols, Summary Reports and other
documentation associated with validations, as appropriate for each validation exercise. ?
- Ensure all validation activities and documents are authorized and appropriate compliance
approval is gained. ?
- Ensure that all validation activities are carried out and reported in a timely manner. ?
- Ensure compliance through assisting in audits.
- Through effective communication and training initiatives develop staff in projects and validation
teams to ensure that validation projects are carried out in accordance Policies and Procedures.
- Facilitate, encourage and coordinate continuous improvement with respect to validation
activities.
- Keep management informed of significant quality issues in a manner commensurate with the
potential impact of the issue on public health, employee health & safety, company operations,
and/or the environment
Qualification:
- Process knowledge and documentation.
- High understanding of GMP, Compliance, Validation Practices including the system
development life cycle and Regulatory expectations.
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science
with additional IT qualification) with a broad technical/educational skills base
- Working experience of validation computer systems for use in a FDA regulated environment.
- Must be able to lead and give direction to Validation Projects and Teams. ?
- Individual must also be an active team member in Validation activities
- Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent
carrying out validation and/or testing activities
- A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT
qualification) with a broad technical/educational skills base and substantial related experience is
desirable
- In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the
medical device industry are desirable
- English and German spoken and written
Projektstart:
- asap
Dauer:
- ca. 6 Monate
Umfang:
- 40 Std. / Woche (100 % vor Ort)
Ort:
- Salzburg (Österreich)
Bei Interesse senden Sie uns bitte Ihr englischsprachiges Profil als Word-Datei und Ihren Stundensatz (inkl. aller Nebenkosten für Österreich) an
Wir melden uns dann in Kürze bei Ihnen zurück.
Vielen Dank!
Christoph Jöckel
Geschäftsführer
JLink connecting experts GmbH
Uhlandstraße 4-5
10623 Berlin
Deutschland
Zentrale:
Fax:
Internet www.jlink.de