COMPLIANCE LEADER (f/m)

CordenPharma Brussels
Brussels, BE
Full-time

CordenPharma Brussels

Brussels, BE
Full-time

REPLACEMENT CONTRACT: 6 MONTHS

Corden Pharma is an expert Contract Manufacturing partner, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives. Formed as a pharmaceutical branch of International Chemical Investors Group (ICIG) in 2006, Corden Pharma provides specialized technologies, grouped under six technology platforms that are ideal for the development and manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients, and associated Global Supply Chain and Packaging Services. As a full-Service CDMO for the global market, Corden Pharma is committed to bringing inspired global service and flexible solutions, spanning the entire pharmaceutical product continuum. The company’s chemists and engineers are widely recognized for their history of innovation, having developed highly efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds.

With multiple cGMP compliant facilities across Europe and the United States, Corden Pharma is the flexible, efficient, and cost-effective solution for all contract manufacturing needs.

For our Peptide API manufacturing subsidiary located in Brussels, Belgium we are currently looking for a qualified

Compliance Leader (f/m)

The Compliance Leader will be working as part of the Corden Pharma Brussels 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

Main Activities:

  • >> 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 Corden Pharma 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 of question regarding the Corden Pharma Brussels 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

    Key Competencies Necessary to Effectively Perform this Job

    Minimum experience required:

    • >> 10 years in a QA position

    Minimum qualifications:

    • >> Master degree Sciences

    Specific skills required:

    • >> Perfect knowledge of cGMP in a regulated environment
    • >> 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

If you are seeking a new challenge in an international and dynamic environment, please send your CV including references and cover letter as well as your salary expectations and earliest availability.

APPLY HERE