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