Complaints Analyst

As a Complaints Analyst accountable to ensure, together with the complaint specialist, a qualitative treatment of complaints regarding a product group.

Responsibilities:

• Performing and documentation of the complaint investigation in the digital complaint database 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
• Responsible for the evaluation of received complaint samples and escalating to the complaint specialist based on the findings
• Responsible for evaluation of reference samples together with complaint technician
• Give support to the complaint specialist when required to coordinate additional investigations
• Give support to the Complaint Specialist in the monitoring and follow-up of the trending of complaints on a daily basis. By using the necessary statistical tools and mapping the complaint ratio
• Ensure complaint management in a timely manner and in accordance with PQS, GMP and relevant medical device and combination products requirements
• Give support in maintaining and improving the IMEx elements
• 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:

• Bachelor in the pharmaceutical and/or biological manufacturing or scientific field
• No experience needed but preferred two or more years of relevant experience in pharmaceutical, GMP environment or combination product or medical device industry. Strong written communication skills: for technical reports
• Strong written communication skills: for technical reports
• Analytical skills (data analysis)
• Persuasiveness: you can bring different parties together to arrive at the best possible solution Good time management and prioritizations skills
• Organizational skills
• Team player
• Proven problem solving abilities
• Fluent in Dutch and English