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Senior QA Associate-LEIDEN

Posted 23 Mar 2024
Work experience
8 to 10 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Fluent)
Dutch (Fluent)
Deadline
2 Sep 2019 21:59

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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Vaccines & Prevention</STRONG>, we are searching for a Senior QA Associate .

Company profile

Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Department

The Quality Assurance department at Janssen Vaccines & Prevention in Leiden is a fast-developing department. Janssen Vaccines & Prevention is currently working on a full Vaccine pipeline, developed at our site in Leiden and by external collaborations. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities. The opportunities and responsibility for the Quality Assurance department to shape and deliver the right quality are key for the success of Janssen Vaccines & Prevention. The team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.

Job description

As Senior QA you assure compliance with regulatory requirements and internal J&J procedures via oversight and planning, conducting, and reporting quality inspections, report audits, internal and external facility evaluations, system audits and data reviews that support company late stage development projects. Furthermore, you will support release activities.

Key responsibilities:

  • Supplier management including auditing, monitoring and maintenance of Quality agreements suppliers including external manufacturing, laboratories, GMP services and GMP raw material suppliers;
  • QA oversight of validation, qualification activities connected to drug substance and drug product manufacturing;
  • Assess compliance with regulations for late stage development matters;
  • Participate in regulatory agency inspections, (global) project team meetings, and training activities;
  • Effective stakeholder manager, able to influence. The ‘go-to’ person on difficult content issues;
  • Involved in conception of new ideas with respect to improvement of business processes or procedures;
  • Lead the execution of systems aimed at evaluating and maintaining quality and compliance;
  • Draft, revise, review and contribute quality assurance guidelines to R&D standard operating procedures;
  • Lead process improvements and contributes to the ongoing development of new procedures, techniques and departmental guidelines.
  • Prepare batch (DS and DP) dossiers to facilitate technical release.

Who we're looking for

We are looking for an experienced candidate with minimally a MSc in a relevant discipline like Pharmacy or Bio-Pharmaceutical Sciences. You have at least 8 years of experience, of which 5 years relevant to this position (industrial setting/manufacturing and/or Quality Assurance area). As a person, you are pro-active, agile, and enjoys working in a team. Good organizational and communication skills, creativity, problem-solving capabilities and a can-do mentality are key for this position.

Lacquey is in 2010 opgericht als spin-off van de TU Delft en hield zich aanvankelijk bezig met het ontwikkelen van robot grijpers voor kwetsbare producten, zoals groente en fruit.
Onze klanten zijn de bedrijven die groente bewerken, combineren en verpakken, waarna consumenten de producten kunnen kopen in o.a. de supermarkt. Het goed kunnen monitoren en controleren van alle productstromen in deze fabrieken is onze klanten veel waard.

Engineering
Delft
7 employees

What employees are saying

Tom Loomans

Chief Information Officer

"Out of the box" wordt vaak geroepen, maar als zelfs je leveranciers zich verwonderen over hoe je hun producten naar nieuwe hoogte brengt, dan ben je echt out of the box bezig. En dat is waar we hier goed in zijn. Complexe problemen lossen we op een…

Evert

Lead Software Engineer

Bij Lacquey kan ik doen wat ik het liefst doe; werken aan hightech machines van de toekomst. Je wordt betrokken in het gehele ontwerpproces waarbij je over een heel breed scala ontzettend veel leert en dat maakt het voor mij zo leuk. Het team bestaat uit mensen…