Project Lead Compliance Improvement - QA

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Project Lead Compliance Improvement / Leiden, Netherlands/6 Months Contract / 38 to 59 EUR (Per Hour)

Johnson & Johnson are seeking a Project Lead - Compliance Improvement.

The Role

Oversees the timely execution and implementation of the Compliance Improvement Plan. Coordinates the required actions and prepares regular status and progress updates.

Gives advice and practical support to the improvement of Mentor’s Quality System. Site CAPAs, audit observations and own analysis will be used as a basis. He will work in close collaboration with the Plant QA Manager.

The Company

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

Principal duties and responsibilities

*. Identify key opportunity areas and implement actions and projects in collaboration with other related departments to improve the site state of compliance with applicable regulations.

*. Establish a Compliance Improvement Plan

*. Ensure that CAPA action plans from different areas/manufacturing departments are complete in the established frame time and that results previously established are achieved.

*. Participate in the execution of CAPA/Observations action plans as required

*. Coordinate, direct cross-functional groups.

*. Prepare regular status and progress updates for senior management review

*. Evaluate compliance risks related to operations, engineering, QC and warehousing processes

*. Improve / update the Quality System based on previous bullets

*. Training of personnel with regard to applicable Standards and Regulations

*. Support the site in preparations for audits and inspections

Experience and background

* Bachelor Degree and/or 5 to 10 years in Quality Assurance and/or Medical Device Industry

* Project Management Skills

* Must have Medical Devices and/or Pharma environment experience

* GMP knowledge and understanding required

* Process Excellence / Six Sigma Certification or equivalent preferred

* Self starter and independent

* Regulatory Compliance knowledge and sills

* Advanced Quality Systems knowledge

* Interpretation and application of QSR and ISO Standards

* Excellent communication and interpersonal relation skills

* English, fluent (Dutch is a plus)

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.