Beschreibung
We are looking for qualification engineer to provide support for the Commissioning and Qualification activities associated with equipment, facilities and environment ensuring compliance with required regulations
Primary Tasks and Responsibilities
Serves as technical expert for the Qualification process and responsibilities to ensure compliance
Suggest and implement innovation and continuous improvement within the Qualification process
Manages relationships externally and internally.
Builds cross-functional and cross-departmental support, fostering overall effectiveness
Review and approve Qualification Master Plans, Protocols, Summary Reports and other documentation associated with Qualification, as appropriate for each Qualification exercise.
Ensure all Qualification activities and documents are authorized and appropriate compliance approval is gained.
Ensure that all Qualification 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 teams to ensure that Qualification projects are carried out in accordance with Johnson & Johnson Policies and Procedures.
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
Requirements:
University degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
Strong experience carrying out Qualification tasks
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the biopharmaceutical industry
High understanding of GMP, Compliance, Qualification Practices including the system development life cycle and Regulatory expectations.
Working experience of computer systems for use in a FDA regulated environment.
This is 6 months contract for more information please call Beata Klecz on (see below).
Michael Bailey International is acting as an Employment Business in relation to this vacancy.