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QA Specialist Complaints
Responsible position within an international environment / Promote a culture of continuous improvement and quality
Het bedrijf / The company
Our client is an innovative, global pharmaceutical organization, with presence in approximately 100 countries worldwide. Our client is science orientated and challenges itself in being a dedicated entrepreneurial in Pharma. At their location in the Netherlands, medicines are labelled, packed and distributed to various countries around the world. Within the organization more than 500 professionals work together to maintain the high quality of the product, which will be distributed to the rest of Europe. Because of internal movements the organization is looking for an experienced QA Specialist Complaints.
De functie / The role
Product complaints investigations are about improving the patient"s experience with the products by providing timely, thorough, and patient focused investigations. These investigations identify and implement corrective and preventative actions that promote a culture of continuous improvement and quality. As Specialist Complaints, you lead and manage product complaint investigations, product security investigations, safety quality investigations, trend investigations and consolidated investigations for the products. You apply analytical skills to evaluate complex situations, and execute regulatory and SOP requirements. You anticipate and prevent potential issues with regulators, and partner with corporate product quality surveillance, assessors, and contracted suppliers to resolve product complaint investigations. You also provide guidance and technical advice and evaluate subject matter expert assessments. Furthermore, you act as site representative in the product complaint network, you attend network meetings and provide meaningful input and expertise. You are responsible for performing data analyses and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. You liaise with Operations, Warehouse, Packaging Development and Engineering to provide information on complaints for process improvement initiatives, and you train staff in complaint handling procedures. You support audits (internal and third party) and Regulatory Inspections by presenting the company"s product complaint system and records and follow-up on commitments.
Het profiel / Your profile
o M.Sc. in Pharmacy, Industrial Pharmacy, Bio-engineering or comparable
o good knowledge of Quality Assurance principles, GMP and GDP
o experience in Quality Assurance, including handling product complaints investigations
o track record of success in an international working environment
o experience leading investigation in Operations (Root Cause Analysis)
o able to maintain oversight on different projects, dive into details when required, work in teams and communicate effectively with all kind of stakeholders
o fluent in both English and Dutch
Het aanbod / The offer
o prominent role within a solid and strong pharmaceutical company
o a great opportunity to be part of a growing company
o responsible role within the QA department
o work on your own development with valuable opportunities to broaden your experience and maximize your potential
o attractive benefits package
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-045-FMF to Vera Hudepohl : email@example.com.
For further information, please call Vera Hudepohl at number +31 (0)33 472 80 87.
Tenslotte ..... / Finally ....
An individual assessment may be part of the selection procedure.
Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.