QA Specialist Biomaterials
Corbion
Gorinchem
21 minuuten geleden

Corbion develops sustainable solutions to improve the quality of life for people today and for future generations.

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.
  • Develop and implement a 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.
  • 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 Life Sciences or other relevant area
  • Minimum 5 years of quality assurance and regulatory affairs experience in pharmaceutical, medical device or other related industries.
  • Experience inimplementation 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 preferably 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 10-20% as determined by business requirements.
  • Our offer

    We offer competitive remuneration and benefits. What makes Corbion special is the way we consciously create that connection between the product of our work and our individual lives and use it to shape our choices and our priorities as a company.

    We have a great company made up of talented, dedicated people people who share a purpose and a vision. When we all understand how we intend to get there in the same way, there’s no telling how far we can go.

    We offer you the chance to join a company with a :

  • Culture to empower people and where your initiatives and ideas make a real difference
  • International focus with truly diverse teams
  • Unique possibility to be trained by our internal expertise in the world of biobased products
  • We invest in relevant training courses related to your particular discipline, that will give you the opportunity to grow into an industry expert
  • Lastly, we offer a friendly, informal culture in a demanding professional environment
  • In addition, we actively embrace diversity in how we work together and contribute toward our shared objectives and values.

    By joining Corbion, you will become an employee in a company where you can feel pride in your achievements and develop your career with global prospects.

    About Corbion

    Corbion is the global market leader in lactic acid, lactic acid derivatives, and a leading company in emulsifiers, functional enzyme blends, minerals, vitamins and algae ingredients.

    Our sustainable ingredient solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics.

    With a worldwide network of production facilities, sales offices and agents in more than 100 countries, Corbion is known for quality, product innovation, and customer orientation, as well as for its collegial, informal and results-oriented company culture.

    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 our 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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