Quality Systems Manager

CordenPharma Brussels
Brussels, BE
Full-time

CordenPharma Brussels

Brussels, BE
Full-time

Founded in 1987, Corden Pharma Brussels (formerly Peptisyntha) was part of the Solvay Group until it was acquired by CordenPharma in October 2013. For 26 years, Corden Pharma Brussels has been producing cGMP API peptides for small and large scale customers in the pharmaceutical and biotechnological fields. Its expertise is internationally recognized. Through its know-how and capabilities in the field of production technologies, Corden Pharma Brussels evalues and adapts its way of manufacturing to provide customers the most efficient production process possible.

Corden Pharma Brussels has developed its own portfolio of innovative technologies with the aim of improving synthesis processes, controlling quality and simplifying (or eliminating) HPLC purifications for short peptides.

As part of his/her role the Quality Systems Manager will ensure:

  • >> the continuous improvement plan of Corden Pharma Brussels is implemented
  • >> the facilities / equipment’s / systems are properly validated / qualified acc. GMP guidelines

The Quality Systems Manager will be part of the Quality Assurance Department and will report into the Head of Quality. Under the direction of the reporting manager, he /she will continuously improve Compliance systems, 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

  • >> Actively contribute to continuous improvement plan of Corden Pharma Brussels :
    • >> Developing and implementing a Quality System based on Business process approach
    • >> Managing Operational Excellence initiatives
  • >> Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems.
  • >> Collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification.
  • >> Provide quality guidance for the development of the validation approach.
  • >> Assure requirements traceability throughout the whole project validation file
  • >> Ensure the review/approval of documentation pertinent to equipment /systems validation/ qualification is timely performed to achieve compliance to procedures and regulatory requirements.
  • >> As member of the Quality department :
    • >> Evaluation / Approval of deviation and support to related investigations
    • >> Operate the change control system (risk assessment, assessment of validation / qualification needs ; follow up )
    • >> Operate the CAPA system
    • >> Work with relevant departments to ensure timely closure of quality actions / findings
    • >> Perform inspections/internal audits and provide quality oversight for the inspection/ audit program
    • >> Collaborate with operations to resolve compliance matters

Background / Skills Requirements

  • >> Engineering degree
  • >> 8 years experiences with 3 years in an operational role in a GMP environment
  • >> Very good knowledge of GxP in a regulated environment
  • >> Knowledge of risk assessment / validation /quality systems
  • >> Excellent accuracy and attention to detail
  • >> Excellent interpersonal skills
  • >> Strong problems solving skills, issue resolution and root cause analysis
  • >> Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
  • >> Working knowledge of computer packages
  • >> Knowledge of Quality Software Systems( Trackwise , Lab software ,…) is an asset
  • >> Language : English , French

Interested and enthusiastic about this job? Please send us your application!

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