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QC manager (Manager Qualite Controle)

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The company

Our client is a professional Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium. The client has developed his own portfolio of innovative technologies in order to improve synthesis processes, control quality and simplify (or eliminate) HPLC purifications for short peptides.

Role description

The Head of QC will be working as part of the Quality department ensuring products are manufactured, stored and packaged in accordance with cGMP.
He / she will be responsible for ensuring timely, accurate completion of QC testing performed both in house and at vendors.
In addition, he/she provides strategic input regarding lab organization and structure.
Under the direction of the reporting manager, continuously strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.

Responsibilities

Management up to 12 QC team members
Supervising implementation and progress of the QC activities
Managing SOPs, change controls, deviations, OOS and CAPA
Ensuring smooth running of the lab: on-time & GMP-compliant analyses;
Develop and/or review departmental documentation including test methods, SOP’s, protocols and reports ensuring compliance with cGMP and applicable regulatory guidelines
Validation of Analytical methods : need to be able to set up and write validation protocol , to analyze the validation results and provide conclusion , to release the validation report
Implementing and validating the new analytical methods after development phase done by R&D team (write validation protocol, analyze the validation results and provide conclusion )
Stability studies management and results interpretation
Review and Approval of analytical dossier
QC Release of raw materials, intermediates products and finish product
Technical support during customer audit and regulatory inspections (FDA, AFMPS, other)
Coordinate laboratory equipment acquisition, qualification, calibration and preventative maintenance.
Leading QC optimization processes and Operational Excellence QC project
Ensuring good relationship with internal and external stakeholders

Requirements

8 years with 5 years in a similar role in the pharmaceutical industry (API is an asset)
Strong laboratory skills and good knowledge of analytical chemistry
People management experience (Leadership experience)
Strong problems solving skills, issue resolution and root cause analysis
Very good knowledge of cGMP in a regulated environment (US and Eur)
Experience with guidelines , standards (ICH, Pharmacopea, 21CFR part 11)
Experience with regulatory inspection (FDA and AFMPS)
Customer oriented, team player, focused on improvement
Excellent interpersonal skills
French, good knowledge in English

Other information



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

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SIRE Life Sciences®

Ref. number: 44921
Listed by: SIRE Life Sciences®
Listed on: 03-01-2019
Country: Belgium
Region: Brussels Hoofdstedelijk Gewest
Employment: Permanent
Expertise: 6 - 10 years
Location Type: On location
Education: Bachelor
Language: French
Sector: Pharmaceutical
Specialisation: Laboratory

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Contact

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