Senior Associate - Quality Assurance Lab
Location:
Geel site in Belgium, hybrid working 3 days a week on site
Duration:
8 month contract
Hours:
40 hours
Imagine your next project working as a QA Point of Contact for QC laboratories within a global leader in innovative medicine, where your expertise in compliance and analytical troubleshooting will directly impact patient safety and product supply.
roles and responsibilities.
* 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
Handling of lab related deviations by:
* Supporting experts in finding root causes
* Defining, following up and concluding corrective and preventive actions
* Evaluating trends in issue investigations and defining appropriate actions
* Approving analytical method transfers
* 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
* 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
how to succeed.
* Master Scientific degree with a technical specialization in analytics/chemistry/biotechnology (or equivalent through experience).
* 5-8 years of relevant experience in Pharmaceutical Quality Control and Quality Assurance
* In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures
* In-depth knowledge in non-conformance handling
* Extensive knowledge of GMP lab compliance guidelines
* 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
* 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 speak and write Dutch and English fluently
benefits.
This role offers a very competitive hourly rate. This contract will run for 8 month contract.
you are welcome here.
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.
Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
application process.
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
We can not consider LTD / Freelancers for this role
Diversity, Equity & Inclusion.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".