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Specialist QA Complaints / Full-time / nearby Breda / Bio-pharma

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Brabant Netherlands. Our client is an U.S. based company with presence in approximately 100 countries worldwide. They discover, develop, produce and distribute therapies that have the power to restore health or save lives. Our client is a value-based organization with a powerful sense of shared purpose towards our mission: “To serve patients”

In the Netherlands, our client is based in Breda. Here medicines are labelled, assembled, packed and distributed to various countries worldwide. At the Breda site, more than 500 people are working every day on the manufacturing and distribution process. They encourage their team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities in a growing and dynamic business environment.

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

Role description

Our client are searching for Specialist QA Complaints. As a Specialist QA Complaints you lead and manage product complaint investigations, product security investigations, safety quality investigations, trend investigations and consolidated investigations for our client commercial products. You apply analytical skills to evaluate complex situations using multiple sources of information en you execute regulatory and SOP requirements.


Your responsibilities as a Specialist QA Complaints are:

- Anticipates and prevents potential issues with regulators
- Partner with corporate product quality surveillance, assessors from other Amgen 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 Amgen Breda site representative in the Amgen 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 Amgen Breda and Amgen affiliate staff in complaint handling procedures
- Support audits (internal and third party) and Regulatory Inspections by presenting the Amgen product complaint system and records and follow-up on commitments


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)

Other information

Please note:
- an online assessment is part of our recruitment process.
- due to our relocation policy, for this vacancy, we can only consider candidates who reside in the Netherlands or candidates who live on a commuting distance from Breda.

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

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SIRE Life Sciences®

Ref. number: 47585
Listed by: SIRE Life Sciences®
Listed on: 06-05-2019
Country: The Netherlands
Region: Noord-Brabant
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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