Quality Associate

Quality Associate - External Quality

Location: Fully remote - Accepting applications from Belgium & Netherlands ONLY.

Duration: 6 months

Hours: 40 hours per week

Provide QA oversight support for External Manufacturing. Contribute to the ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules (Fill-Finish activities).

Support the External Quality account owner on tech transfers/projects as appropriate.

Requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.

roles and responsibilities

• Serve as a contact point within the QA organisation for other departments of both Janssen and the external manufacturer with respect to quality relevant subjects. Build relationships and influence external partners to continuously enhance quality culture and business excellence.

• Perform review of equipment and facility qualification, PPQ documentation,  environmental monitoring, technical documents, raw material specifications, analytical methods, and master batch records to ensure products and processes comply with cGMP requirements.

• Provide QA support for technology transfer and improvement of existing manufacturing processes

• Following and during successful tech transfer, support day-to-day quality oversight for production activities, including identification of risks, deviation and CAPA management, Complaint handling, change control, and batch documentation review.

• Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to the External Quality Account Owner.

• Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs

• Apply applicable GMP regulations international requirements to all aspects of the position.

• Support regulatory inspection readiness at the external manufacturer for Janssen products.

• Monitor trends, identify issues, recommend, and implement appropriate actions.

how to succeed

• Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline

• Solid (> 5 y) knowledge of GMP, specifically:

• Aseptic manufacture (sterile, liquid dosage forms products and/or Large Molecule) experience is preferred (QA and/or production). 

• Able to connect easily, team worker, able to manage across cultures.

• Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required

• Able to think outside the box and come up with solutions to problems. Open-minded for new ideas and willing to pivot when necessary.

• Strong interpersonal and written/oral communication skills

• Advanced degrees are a plus and may reduce the experience required

• Proficiency in English is a must

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months. 

you are welcome here

Johnson & Johnson Innovative Medicine 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.

Janssen UK: https://www.janssen.com/uk/

application process

We do not accept applications via email.

The pay rate for this role will depend on how you are paid.

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”.