Compliance Leader

Recruteur
Experis IT
Région
Bruxelles (BE)
Publication
mercredi 5 décembre 2018
Date limite
samedi 19 janvier 2019
Réf
4657
Type de contrat
CDI
Temps de travail
Temps plein

Compliance Leader

Do you have a relevant experience in quality ? The pharmaceutical workfield don't have any secrets to you? Are you looking for manage a team? This job is for you!

Organization

Our client is a pharmaceutical industry located in Brussels areas.

Function description

The Compliance Leader will be working as part of the Quality Assurance Department and ensure that the products are manufactured, stored and packaged in accordance with cGMP regulation.

The Compliance Leader will be working as part of the Quality Unit on site ensuring products are manufactured, stored and packaged in accordance with the cGMP.

Under the direction of the Head of Quality, he/she will be in charge to improve continuously the Quality system regarding the cGMP requirements. He/She will be a QA support in case of quality issues and problem solving techniques to assure the successful outcomes of company and external Health Authority.

He/She will be in direct contact with our customer in case of qualification audit, QA complaint issues and other quality topics. The Compliance Leader is reporting to the Head of Quality...

Principle Responsibilities of the Job Holder

Provide QA support for:

  • Investigation and closure for the Deviation and the Out Of Specifications
  • Change Control initiation and implementation
  • CAPA initiation and implementation

Documentation:

  • SOP and Policy writing in accordance with the cGMP and Policies
  • Batch records reviewing and associated documents after production
  • Control Cleaning Records

Continuous improvement and project support:

  • CPB Improvement support and project leader for the new QA project (ex.: new system implementation)
  • Actively contribute to continuous improvement initiatives

Customer relationship:

  • Point of contact in case of customer audit
  • Customer audit contact for the responses
  • Customer audit contact for all question regarding the compliance aspect

Other activities:

  • TrackWise System Administrator
  • QA KPI implementation and follow-up.
    • QA Trainer (GMP training, Quality issues training, new SOP/Policies,…)
    • Work with relevant departments to ensure timely closure of quality actions
    • Internal auditor
    • Collaborate with the different departments to resolve compliance issues
    • Back-up of the Head of Quality

Skills and experience

  • Master degree Sciences
  • Min.10 years in a QA position
  • Perfect knowledge of cGMP in a regulated environment (ICH guidelines)
  • Knowledge of quality systems in cGMP environment (21 CFR part 11)
  • Excellent accuracy and attention to detail
  • Excellent interpersonal skills (Team spirit, Open for the constructive discussion,…)
  • Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System is in asset
  • Strong problems solving skills, issue resolution and root cause analysis
  • Knowledge in Lean Tools is an asset
  • Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
  • Language: French, English

Offer

Our clients offer an exciting role in a dynamic team as well as a chance to further develop your skills. A permanent contract with an attractive salary package and extra-legal benefits.

Contact me at 02 389 11 76 or diane.louppe@experis.be.

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