QUALITY ASSOCIATE – SMALL MOLECULE API

Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Quality Associate SM-API (M/F/X) as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium.
J&J Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-APIs used in treatments that improve the health and lifestyle of people worldwide.
J&J Innovative Medicine Supply Chain Quality (IM SCQ) SM-API supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-APIs guaranteeing reliable supplies in compliance with applicable regulations.
As Quality Associate SM-API, you are responsible for Batch Record Review, Cleaning Record Review, and the review of Product Quality Reports of an assigned product portfolio of commercial APIs, ensuring compliance with applicable regulations.
You will also provide quality support to the production plants.
Job Description.
Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results.        Work as One team with QA and Supply Chain partners to ensure timely review and approval of Batch Records and Cleaning Records in support of a reliable supply chain.
      Ensure that Product Quality Reviews for the assigned product portfolio of commercial APIs are timely and properly reviewed and approved.
    Ensure that deviations, CAPAs, Change Controls and Product Quality Complaints are timely and properly investigated by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
      Ensure that deviations and complaints with potential impact on patient safety and/or product supply are properly escalated.
      Review of Master Batch Records.
      Support the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation.
      Serve as Subject Matter Expert for assigned Quality Processes and support process improvements supporting business needs in compliance with GMP regulations.
      Act as spokesperson during Health Authority inspections and customer audits.
      With focus on Quality processes, develop and foster an environment of innovative thinking through e.
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benchmarking, training.
Continuously challenge the status quo by identifying opportunities for continuous improvement.  Qualifications Job Qualifications.
·        Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, …) or equivalent through experiences.
Industrial Pharmacist – EU certified Qualified Person is an asset.
·        Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance is an asset.
·        Demonstrated ability to work independently while staying connected with key stakeholders.
·        Demonstrated ability to work across organizational boundaries as a recognized partner.
·        Strong analytical thinking skills and able to work in a flexible way under time pressure.
Ability to make risk based decision under time pressure.
Understands the business implications regarding quality positions and decisions.
·        In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
·        Preferably experience with Quality Systems.
·        Experience with regulatory inspections and preparedness is an asset.
·        You speak and write fluent Dutch and English.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.