Specialist QA Complaints

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Brabant Netherlands.

The Company

At the site, more than 500 people are working every day on the manufacturing and distribution process. Process Development, Operations and Quality are the core divisions that make sure the drugs are delivered to the patients. Product complaints investigations are about improving the patient’s experience with products by providing timely, thorough, and patient focus investigations which identify and implement corrective and preventative actions that promote a culture of continuous improvement and quality.

Role Description

You have a quality background, both in Education (Pharmacist, biomedical, bio-engineering, biotechnology) and you have worked for a few years in a pharmaceutical environment, ideally a manufacturing or operations plant. You are able to maintain oversight on different projects and dive into details when required. Working in teams and communicating effectively with all kind of stakeholders is crucial in this role.

We offer you a great opportunity to be part of our growing company, work on your own development whilst making sure our medicines find their way to the patients who need them.

Responsibilities

Responsibilities, you:

-Lead and manage product complaint investigations, product security investigations, safety quality investigations, trend investigations and consolidated investigations for commercial products;
-Applies analytical skills to evaluate complex situations using multiple sources of information;
-Execution of regulatory and SOP requirements;
-Anticipates and prevents potential issues with regulators;
-Partner with corporate product quality surveillance, assessors from other sites and contracted supplier/ manufacturers to resolve product complaints investigations
-Provides guidance and technical advice;
-Evaluates subject matter expert assessments;
-Escalates potential Quality issues to Management;
-Act as site representative in the product complaint network;
-Attend Network meetings and provide meaningful input and expertise;
-Support Network activities and continuous improvement initiatives;
-Perform data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner;
-Liaise with Operations, Warehouse, Packaging Development and Engineering to provide information on complaints for process improvement initiatives;
-Train staff in complaint handling procedures;
-Support audits (internal and third party) and Regulatory Inspections by presenting the product complaint system and records and follow-up on commitment;

Requirements

What do you need to be successful in this role?

-You have a master’s degree (e.g. in Pharmacy, Industrial Pharmacy, Bio-engineering,…) and 3+ years of experience in pharmaceutical industry;
-Fluent in English;
-You have sound knowledge of Quality Assurance principles, Good Manufacturing Practices and Good Distribution Practices;
-Computer literacy;

Preferred Requirements

-You have experience in Quality Assurance, including handling product complaints investigations;
-Track record of success in international working environment;
-You have experience in leading cross functional teams;
-Experience leading investigation in Operations (Root Cause Analysis);

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.