Complaints Specialist

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team.?

Let's look together at your first challenge with us!

Complaints Specialist

Scope of work:

• Carrying out, documenting and reviewing the complaints, including evaluating the possible impact on the patients and providing an answer to the hospital / care provider / patient.
• Guaranteeing the correct balance statement by investigation level per type of complaint. It is important to be able to differentiate between product-related complaints that are specific to the product and process-related complaints, which can be caused during our production process and thereby rationalize the appropriate level of research.
• Monitoring and follow-up of the trending of complaints on a daily, monthly, quarterly and annual basis. By using the necessary statistical tools and mapping the complaint ratio. Based on this, an evaluation is made of the need to start up additional actions with the intention of reducing the complaint ratio.
• In the case of process-related complaints, act as a facilitator between the involved departments, work with experts from production, product support and other departments and lead the cross-departmental meetings on this and guarantee that the investigation is conclusive.
• Ensure notification to higher management regarding significant quality issues and complaints and corrective & preventive actions taken.
• Ensure complaint management in a timely manner and in accordance with PQS, GMP and relevant medical device and combination products requirements.
• Respect the PGS vision, mission, values and leadership behaviors in order to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time.

Profile:

• You have a master’s degree in the pharmaceutical and/or biological manufacturing or scientific field.
• You have strong written communication skills: for technical reports
• You have good analytical skills (data analysis)
• You are persuasive: you can bring different parties together to arrive at the best possible solution
• You have good time management and prioritizations skills
• You are a team player
• You have proven problem-solving abilities
• You are fluent in Dutch and English