QRA Specialist
Location: NetherlandsSIRE® 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 Healthcare organisation, based in Zuid-Holland Netherlands.
Furthermore we offer a broad role that is focused on:
- Release of final products for the market and release of raw materials for production purposes
- Release of orders for the market
- In the framework of day to day business ensure compliance to international standards, legislations and customer specifications and regulatory requirements
As the QRA Specialist we need you to:
- take responsibility for customer audits with the ultimate quality goal that the unit is the supplier of choice for the customers
- handle customer requests, deviations, changes, CAPA's and using an electronic quality management system
- monitor and identify developments to legislations/requirements and translate these to the Business Unit Biomaterials in order that compliance is assured
- ensure that employees of the business unit are educated to the appropriate quality requirements
- maintain quality & regulatory affairs oversight and provide suitable and optimal support in the day to day business and new products & technology projects
- plan and execute (lead auditor) external and internal audits
- ensure continuous improvement
- develop, optimize and implement improvements to the quality systems within the various business parts and processes
- at least 5 years’ experience with cGMP, quality systems and pharmaceutical, medical device or food products
- a technical background in chemistry is preferred but not required
- strong communication skills (written and verbally) across organizational levels, cultures and external parties
- ability to communicate in fluent Dutch and English
At Corbion, we look for employees who can:
SET CLEAR DIRECTION: Explain clearly where we are heading, why and how we will get there
MAKE THE DIFFERENCE: Deliver results and quality while managing change
FOCUS ON CUSTOMERS: Consistently meet the expectations of internal and external customers
DELIVER THROUGH TEAMWORK: Engage, motivate, challenge and support employees and teams
As the QRA Specialst we need you to go the extra mile, to embody our behaviors and show the following competencies: Initiative, Self-management, developing others and integrity & self confidence
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.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.
The Company
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. We develop sustainable ingredient solutions to improve the quality of life for people today and for future generations. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. We have factories in the Netherlands, Spain, Brazil, Thailand and the United States. Corbion has a worldwide network of sales offices and agents in more than 100 countries. Quality, product innovation, and customer orientation are important attributes for our client, which is also characterized by being a collegial, informal and result-oriented company culture.Role Description
Do you want to have a key role in ensuring customer satisfaction in the field of quality and regulatory affairs? Corbion now offers the position of QRA Specialist in Gorinchem.Responsibilities
As our QRA Specialist the main responsibilities are to create excellent release of products to the market, assure systems are in place to ensure compliance to GMP / ICHQ7 and propose, develop and implement improvements to the quality systems. In this new position you report to the Director Quality & Regulatory Affairs and work closely with the Director Production, Manager QC and Director SalesFurthermore we offer a broad role that is focused on:
- Release of final products for the market and release of raw materials for production purposes
- Release of orders for the market
- In the framework of day to day business ensure compliance to international standards, legislations and customer specifications and regulatory requirements
As the QRA Specialist we need you to:
- take responsibility for customer audits with the ultimate quality goal that the unit is the supplier of choice for the customers
- handle customer requests, deviations, changes, CAPA's and using an electronic quality management system
- monitor and identify developments to legislations/requirements and translate these to the Business Unit Biomaterials in order that compliance is assured
- ensure that employees of the business unit are educated to the appropriate quality requirements
- maintain quality & regulatory affairs oversight and provide suitable and optimal support in the day to day business and new products & technology projects
- plan and execute (lead auditor) external and internal audits
- ensure continuous improvement
- develop, optimize and implement improvements to the quality systems within the various business parts and processes
Requirements
In addition to your educational achievements with a Bachelor degree, as the successful candidate for the position of QRA Specialist you must also have:- at least 5 years’ experience with cGMP, quality systems and pharmaceutical, medical device or food products
- a technical background in chemistry is preferred but not required
- strong communication skills (written and verbally) across organizational levels, cultures and external parties
- ability to communicate in fluent Dutch and English
At Corbion, we look for employees who can:
SET CLEAR DIRECTION: Explain clearly where we are heading, why and how we will get there
MAKE THE DIFFERENCE: Deliver results and quality while managing change
FOCUS ON CUSTOMERS: Consistently meet the expectations of internal and external customers
DELIVER THROUGH TEAMWORK: Engage, motivate, challenge and support employees and teams
As the QRA Specialst we need you to go the extra mile, to embody our behaviors and show the following competencies: Initiative, Self-management, developing others and integrity & self confidence
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.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.
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