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Quality Assurance Specialist - Biomedical Polymers

Job Category:  Quality
Work Location:  Corbion Site
Office Location: 

Gorinchem, NL

Job Type:  Full Time but Part Time optional
Job ID:  2738

At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.

 

 

The Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry. Our products are used, among other things, in the production of surgical aids and slow-release medicines (injection pills).

The products are developed and produced (often to customer specifications) in our factories in Gorinchem and the United States. This requires very intensive contact with the customer.

The application area and the specific market require a very high level of quality and service.

 

The Corbion Biomaterials Quality Assurance department ensures that raw materials, production process, packaging, storage, transport and service continuously meet and exceed these high standards. This makes sure that our customers receive the consistent high quality product from Corbion that they have become accustomed to.

 

The Quality Assurance Specialist is responsible for ensuring procedures, systems, and processes effectively meet the Quality requirements and business needs.

 

Responsibilities

 

  • Support in maintaining and continuously improving the quality management system in compliance with ISO 9001 / ICH Q7 / G(A)MP.
  • Support the execution of the Data Integrity Compliance Program including risk assessments.
  • Maintain current knowledge of FDA, EMA and other international regulations, guidance’s, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.
  • Product disposition: Responsible for release of raw materials for production purposes and for release of final product to the market.
  • Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Complaint handling and Personnel Training on QA procedures and the QMS.
  • Support internal and external customers in the field of Quality and Regulatory Affairs by timely follow up on requests and participation in new business development projects.
  • Monitoring and reporting of metrics related to all main QA processes in support of the Management Review.
     

Requirements

 

As a successful candidate you are a seasoned professional with experience in pharma, medical device, food or related FDA regulated industry. You have thorough working knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820 and other applicable regulations.

 

In addition we expect the following qualifications:
 

  • Bachelor’s or Master's degree in Chemistry, Life Sciences or other relevant area.
  • Minimum 5 years of quality assurance and regulatory affairs experience in pharmaceutical, medical device or other related industries.
  • Working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, ISO 13485 and other applicable regulations.
  • Experience in implementation of qualification and validation guidelines for computerized systems, such as GAMP5, 21 CFR Part 11, ICH validation, Eudralex Annex 11.
  • Background in Quality Control, in validating analytical methods, is a plus.
  • Strong written and verbal communication skills, in English and in Dutch.
  • Some exposure to regulatory agency inspections (e.g. FDA, notified bodies, etc.)
  • Proven ability to work cross-functionally to achieve business outcomes.
  • Attention for detail, commitment to quality, accuracy, efficiency, and consistency.
  • Ability to travel occasionally as determined by business requirements.

 

About Corbion 
 

What makes Corbion truly special is our talented global team of people, who are consciously dedicated to connecting the work we do together with the difference it makes in the lives of consumers, including our own friends and families. At Corbion, innovation is in our DNA; we explore, we discover, we create, and then we do it all over again, finding ever-better ways to help the world solve some of its most pressing challenges. When you come to Corbion, you will find that for us, sustainability is not simply a corporate program, it is at the very heart of our business, giving direction to our work, our investments and our creativity. We exist to preserve what matters.

 

As a company where day-to-day priorities and decisions are shaped by a shared purpose and vision, we enjoy a working environment energized by empowerment and opportunity. By joining Corbion, you can be part of :

 

  • A culture open to great ideas wherever they come from, and where your work can make a real difference in the world
  • An organization that values diversity of thought, background and experience
  • A company ready to invest in you, helping you grow toward your personal ambitions
  • A workplace that’s friendly and informal, while being focused and professional
  • An international team small enough to stay agile, but large and talented enough to make an impact today, and for future generations

 

Our corporate values – Collaboration, Care, Courage and Commitment – define what it takes to overcome obstacles and create the sustainable breakthroughs the world sorely needs. As a member of the Corbion team, you’ll see these values put into action every day, and you’ll have the chance to make your own unique contribution to our collective achievements.

 

Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.


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