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 / patientGuaranteeing 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 researchResponsible for the evaluation of received complaint samples and escalating to the complaint specialist based on the findingsResponsible for evaluation of reference samples together with complaint technicianGive support to the complaint specialist when required to coordinate additional investigationsGive 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 ratioEnsure complaint management in a timely manner and in accordance with PQS, GMP and relevant medical device and combination products requirementsGive support in maintaining and improving the IMEx elementsRespect 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 fieldNo 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 reportsStrong written communication skills: for technical reportsAnalytical skills (data analysis)Persuasiveness: you can bring different parties together to arrive at the best possible solution Good time management and prioritizations skillsOrganizational skillsTeam playerProven problem solving abilitiesFluent in Dutch and English