Complaints Specialist

Responsibilities

• As Complaints Specialist you are responsible for 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.
• You will guarantee the correct balance statement by investigation level per type of complaint. 
• You are responsible for 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. 
• You 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.
• You ensure notification to higher management regarding significant quality issues and complaints and corrective & preventive actions taken.
• You ensure complaint management in a timely manner and in accordance with PQS, GMP and relevant medical device and combination products requirements.
• You 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.

Requirements

• This function requires a master degree in the pharmaceutical and/or biological manufacturing or scientific field: Bio Engineer, Pharmacist, Master in Biology, Biochemistry, Biotechnology, Engineering, …
• 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
• Analytical skills (data analysis)
• Persuasiveness: you can bring different parties together to arrive at the best possible solution
• Good time management and prioritizations skills
• Team player
• Proven problem solving abilities
• Talen (Languages): fluent in Dutch and English