Senior QA Associate

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Senior QA Associate – QA-Lab

Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Senior QA Associate – QA Lab (M/F/X) as member of our Quality team overseeing the Quality Control laboratories Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates based in Geel, Belgium.

J&J Innovative Medicine Supply Chain Geel serves as Center of Excellence for the development and manufacturing of SM-API's and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. At J&J Innovative Medicine Supply Chain Quality (IMSCQ) we support the Geel site in its mission as Launch & Grow site and we are responsible for the quality oversight and final release of SM-API's and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

As Senior QA Associate – QA Lab, you have quality oversight of the Quality Control laboratories, responsible for testing of final API, API intermediates, Raw Materials, Packaging Materials as well as Drug Product Intermediates and Cleaning Validation. In this role you report to the Senior QA Manager.

Job Description:

In this role you will be responsible for:

• Establishing and maintaining strong working relationships with your partners in Quality Control (QC) laboratories as well as commercial and clinical Supply Chain

• Acting as QA Point of Contact for the QC laboratories ensuring compliance with global regulations and J&J quality requirements

• Supporting the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation

• Supporting process improvements in the QC laboratories

• Handling of lab related deviations by:

  • Supporting experts in finding root causes

  • Reviewing and approving of lab investigations and deviations

  • Defining, following up and concluding corrective and preventive actions

  • Evaluating trends in issue investigations and defining appropriate actions

• Analytical method transfers: providing support and oversight during analytical method introductions

• Ensuring that quality records such as investigations, CAPA's, Change Controls, analytical method transfer protocols and reports related to the QC area are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met

• Provide QA oversight for projects in the QC laboratories

• With focus on Quality processes, develop and foster an environment of innovative thinking through e.g. benchmark and training. Continuously challenge the status quo by finding opportunities for continuous improvement

• Acting as spokesperson during Health Authority inspections and customer audits

• Ensuring that deviations and complaints with potential impact on patient safety and/or product supply are properly escalated

Job Qualifications:

• Master Scientific degree with a technical specialization in analytics/chemistry/biotechnology (or equivalent through experience)

• Min. 6 years of relevant business experience in Chemical and/or Pharmaceutical Quality Control and/or Quality Assurance, with at least 4 years of experience in an analytical area

• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures

• Strong analytical thinking skills and able to work in a flexible way under time pressure in local and global teams. Ability to make risk based decisions. Understands the business implications regarding quality positions and decisions

• Strong end-to-end process thinker with a solution-oriented mindset

• Strong sense of responsibility with the ability to lead and coordinate. Experience as a people leader is an asset

• Demonstrates resilience and agility to drive and adapt to change

• Ability to handle multiple tasks and collaborate effectively

• Familiar with the concepts and tools related to Analytical Troubleshooting and can apply these in a result-oriented manner

• We are looking for someone who works accurately and proactively seeks solutions and who has the necessary communication skills

• You are a seasoned individual contributor, who works independently with minimal supervision

• You speak and write Dutch and English fluently

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.

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