Quality Assurance (Contractor)

As a Quality Assurance Contractor at Kymanox, you will focus on ensuring compliance with pharmaceutical regulations, leading internal and external audits, and providing guidance on Quality Management Systems. You'll be responsible for reviewing changes and deviations, overseeing CAPAs, and engaging in regulatory inspections to maintain the highest quality standards in life sciences.

To apply for the Quality Assurance Contractor role at Kymanox, candidates should hold a Bachelor’s or Master’s degree in a scientific or technical discipline and possess at least 5 years of relevant experience in the pharmaceutical or biotech industry, along with familiarity with applicable regulations and guidelines.

Yes, Kymanox offers a remote Quality Assurance Contractor position that allows professionals to work from anywhere in Europe. This flexibility contributes to a dynamic work environment, leveraging your skills while enjoying the comfort of working from home.

The ideal candidate for the Quality Assurance Contractor position at Kymanox should have a solid understanding of regulations like 21 CFR 820, ISO 13485, and ISO 14971. Experience in QMS requirements and being a certified auditor are also important as you will represent the QA team during audits and inspections.

Kymanox fosters a positive and collaborative culture where every team member's contributions are valued. As a Quality Assurance Contractor, you will find an environment filled with knowledgeable experts who are dedicated to your growth and learning, while all focused on making a significant difference in patients' lives.

The Quality Assurance Contractor at Kymanox plays a crucial role in guaranteeing the safety and efficacy of life science products. Through diligent quality checking, regulatory compliance, and process improvements, you'll directly contribute to the advancement of modern medicine and patient care.

As a Quality Assurance Contractor at Kymanox, you will work on diverse projects that span the pharmaceutical and biotech spectrum. Your involvement will include everything from supporting medical device development to aligning processes with regulatory standards, all aimed at enhancing product quality and patient outcomes.

In your response, highlight your methods for staying updated with industry regulations, such as attending workshops, reviewing guidelines regularly, and utilizing regulatory databases. Mention how you've implemented these regulations in your past roles to ensure high standards of quality.

When answering, provide examples of your audit experiences, including your roles, responsibilities, and outcomes. Discuss how you prepare for audits and collaborate with auditors to ensure the process runs smoothly and any findings are effectively addressed.

Discuss your systematic method for addressing Corrective and Preventive Actions (CAPAs). Emphasize your ability to investigate the root causes of issues, develop action plans, and track effectiveness to prevent recurrence.

Highlight your analytical skills in assessing the potential impact of changes on the QMS. Explain your process for documenting changes, obtaining necessary approvals, and communicating updates to relevant stakeholders.

Provide a specific example where you identified a process inefficiency. Discuss the steps you took to analyze and improve the process, the implementation challenges faced, and the resulting benefits to the organization.

Explain techniques such as the '5 Whys' or Fishbone diagram that you use for root cause analysis. Provide a real-life scenario where you applied these techniques, focusing on the thoroughness of your approach.

In your answer, mention resources such as professional organizations, conferences, and online courses you engage with. Highlight the importance of continuous learning in your professional development.

Emphasize the significance of collaboration in quality assurance. Share examples of successful teamwork experiences and how you facilitate communication among different departments to achieve common quality goals.

Talk about your approach to conflict resolution, which includes open communication, understanding different perspectives, and finding a compromise that upholds quality standards while satisfying other departmental needs.

Explain your alignment with Kymanox's mission of advancing life sciences and your excitement about working with a talented team. Highlight your skills and experiences that make you a suitable fit for the role, reinforcing your passion for quality in healthcare.