Cqv Life Sciences Belgium

il y a 8 heures

Nivelles, Belgique Group-IPS Temps plein

**Job Information**

Salary
**TBD**

Work Experience
**1-3 years**

Industry
**Life Sciences**

City
**Nívelles**

State/Province
**Wallonie**

Country
**Belgium**

Zip/Postal Code
**1400**

Group-IPS is active within the Pharmaceutical, Biotechnology, Cell & Gene Therapy, Medical Devices and Cosmetics industries and currently looks for a Commissioning, Qualification and Validation Coordinator who joins the Life Science Business Unit based in our Antwerp or Nívelles office
*
Your Challenge*
- Be in charge of supporting Discipline Engineers’ team during projects to prepare and execute SAT/IOQ for all systems in the scope of our missions. Objectives are to comply to cGMP and project Validation/Qualification strategy;
- Be the Single Point Of Contact (SPOC) for qualification coordination with other project teams (QA, qualification team, etc.). Specially to define detailed leveraging strategy (early project stage), validation scope and final requirements review and tracking;
- Write, review and approval follow-up of strategic documents such as Validation Master plan or Qualification/Validation plan;
- Develop CQV planning documents to manage CQV projects;
- Perform risk assessments and impact assessments;
- Lead the team in generating and executing CQV protocols using Good Documentation Practices (GDPs), in Investigating and resolving protocol exceptions or discrepancies, and in developing technical reports and CQV summary reports;
- Establish appropriate procedures regarding the handover of systems from construction to C&Q team as well as the handover of systems from C&Q team to the client;
- Establish appropriate metrics for measuring key project criteria;
- Ensure that project deliverables satisfy project requirements;

*
Requirements*
**Education**:
Master in Bio-technologies, Mechanical or Chemical engineering or equivalent.

Strong working knowledge of commissioning, qualification and validation deliverables, team building and client relationship building.
*
Experience: *

More than 3 years of CQV experience in the life sciences industry.

Proven experience with international pharmaceutical projects.
*
Skills: *
- Proactive and strong leadership skills.
- Creative, high flexibility while working, result driven, team working but also high autonomy.
- Extensive skills in management, effective communication, and problem-solving.
- Customer oriented and presentation skills.

**Languages**:
Fluent in French/Dutch and English is a must.

Any other language is an asset.
*
Other: *

AutoCAD and/or MS Project is an asset.

Driver license B

*
Benefits*
IPS offers you a challenging job in a dynamic and international environment with professional growth potential. Quality and professionalism are our hallmark. As a member of our team, we are able to offer you a full-time employment with group insurance, laptop, GSM as well as other fringe benefits.

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