Careers

QA Validation Specialist

CordenPharma Brussels
Brussels, BE

CordenPharma Brussels

Brussels, BE

Our Company

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

Role

As QA Validation Specialist you will be working as part of the CordenPharma Brussels Quality Assurance Department. You will manage the qualification plan to maintain the accurate validation and qualification state of facilities and systems. You will collaborate in several projects as Quality Representative for equipment, system validation and qualification.

As a member of the QA department, you will be in charge of the evaluation and approval of deviations and support to the related investigations. You will also operate the change control and CAPA system

Duties and responsibilities

  • >> Provide quality guidance for the development of the validation/qualification approach.
  • >> Assure requirements traceability throughout the whole project validation file
  • >> Ensure that the review, approval of documentation pertinent to equipment, systems validation and qualification is performed on time to achieve compliance to procedures and regulatory requirements.
  • >> Review and approval of SOP related to validation activities
  • >> Review and approval of validation documents (protocols, reports, executed protocols, risk assessments, rationales) related to: QC and production Equipment/System validation/IT
  • >> Review and approval of change control / validation deviations
  • >> Actively contribute to continuous improvement plan of Corden Pharma Brussels (Quality system, Operational Excellence initiatives, etc)
  • >> 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

Qualifications and skills

  • >> Engineering degree, Master of Science
  • >> Min.5 years in a QA position
  • >> 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
  • >> Strong oral & written communication skills (English & French)

What we offer

We offer a permanent contract, a competitive salary package and varied and motivating responsibilities.

Interested?

Then we should definitely get to know each other. We look forward to receiving your application via the button Apply or send it to [email protected]

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