Test Method Validation Engineer (Medical Device)

Switzerland  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Beschreibung

Validation Engineer (Test Method Validation)

For a significant Medical Device Company based in Switzerland, i am looking for the following qualification.

TMV:
  • Originate TM assessment including protocol and plan for outlined CCPs or other control points
  • Coordinate required actions and assure that TMV are completed on time
  • Originate and approval of Test Method Validations including of determination of sample size and worst case parts
  • Draft and review Job Breakdown Sheets including conducting of 4-Step Method training
  • Establish adequate documentation for CAPA action - Conduct transfers of TMV protocols and plans


CSV/Validation:
  • Originate requested documents for validation and computer system validation with support of
  • Subject Matter Experts
  • Coordinate actions and assure that deliverable are completed on time


Others:

Able to write technical documentation (work instructions, risk assessment and plan, etc.)
General Description:

To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of Company's Validation Policies and Procedures are addressed.

Primary Tasks and Responsibilities
  • Serves as technical expert for the Validation process and responsibilities to ensure compliance
  • Continuous Learning/Managing Risk
  • Resolves & manages technical operational problems in area of expertise
  • Suggest and sometimes may implement innovation and continuous improvement within the Validation process
  • Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
  • Facilitates successful team behaviour within Quality Systems and across functional areas
  • Manages relationships externally and internally.
  • Builds cross-functional and cross-departmental support, fostering overall effectiveness
  • Fosters harmony within Quality Systems.
  • Influences and persuades so as to bring about technical and process improvements.
  • Ensure accuracy and maintenance of the company's 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 authorised 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 with company's Policies and Procedures.
  • Facilitates, 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
  • Lead by example, inculcating the Credo values in all actions within the workplace


Technical Profile Requirements
  • Knowledge of bespoke validation.
  • Process knowledge and documentation. Desirable:
  • In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
  • High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
  • Working experience of validation computer systems for use in a FDA regulated environment. Non-Technical Profile Requirements
  • Must be able to lead and give direction to Validation Projects and Teams.
  • Individual must also be an active team member in Validation activities Methodology/Certification Requirements
  • Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
  • Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities.


Desirable:
  • 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
  • Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.


If you feel that you could match the requirements above or if you wish to discuss similar positions, please get in contact with me and send me your CV upfront to ...



I wish you nice time and hopefully we get to speak soon.

Best Regards

Sabina Keel
Start
02/2017
Dauer
12 months
Von
Real Staffing
Eingestellt
24.12.2016
Projekt-ID:
1260353
Vertragsart
Freiberuflich
Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
Registrieren