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05.04.2016

QA Change Management Specialist

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.

My client is one of the world leading Medical Devices.

ROLE DESCRIPTION

- Working under general supervision using initiative and judgement ensures compliance to Change Control processes and procedures.
- Leads & executes the change control board
- Assesess document changes for applicability to responsibility matrices & compliance to processes.
- Supports and coaches the Change owner.
- Act as change analyst & change approver, review of changes regarding documentation, plausibility, correct classification, compliance with the specified standards and regulations, particularly the rules applicable CC procedures .
- Reviews for sound rationale, justification and resulting status of change requests.
- Be Process SME and will assist in audit representation
- Co-ordinate the change control process plant-wide ensuring timeliness in compliance with procedure.
- Updates and training of change control process procedures and forms.
- Collation and reporting of specific KPIs, data analysis, support for the collection of quality data and preparation of reports, management forums.
- Operation and maintenance of databases (e.g. wind chill )
- Interface between divisions & GQO sites, interface function to other departments such as Design, Quality and Operations at product, process, system, or supplier related changes.
- Implementation of internal and external policies
- Development and implementation of training courses.
- Promote development and implementation of quality data and reports to improvement and optimization of business processes/results
- Identify and report any quality or Compliance concerns and initiate immediate corrective actions if necessary
- Ensuring compliance with the quality regulations (QSR), the cGMP requirements through participation in internal audits, support the reduction of essential critical Audit objections

RESPONSIBILITIES

See above

REQUIREMENTS

- Bachelor or Master in a science, engineering or related discipline. Minimum of 2 years experience in Quality Management Systems Minimum of 5 years in
Quality/Regulatory Affairs environment
- Activities required degree of autonomy and responsibility: First insights into
Change Control, QA management or R & D desirable Experience in CIP processes
- Good technical overview required
- General computer skills
- Good verbal manner in English
- Good understanding on cooperation of the results of his own team with those of the other teams in the own department
- Knowledge of coordinating tasks and resources in their own team
- Promote achievement of your team
- Knowledge of the complement and support different teams in their own department
- Leadership - No management responsibility
- Troubleshooting - The position requires an experienced evaluation assets in novel situations
- Select and apply standardized solutions
- Expected independence in the provision of high-quality work results - type of influence
- Alternative ways of work instruction
- Influence through information / counseling or performance for other
- Proportionally responsibility for quantity, quality and timeliness
- Sphere of influence - is on teams in their own division which worked closely
- Communication - Solid and comprehensive communication and diplomatic skills
- Exchange of complex information at the team level
- Partially sensitive issues, which are difficult to communicate due to the content or information

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.



 
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