As a Complaints Analyst accountable to ensure, together with the complaint specialist, a qualitative treatment of complaints regarding a product group.
You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
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 xphnsxz 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