Technical QA Specialist

Bedrijfsnaam: -
Plaatsingsdatum: 29/03/2019
Standplaats: -

Functieomschrijving

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 organisation, based in Noord-Brabant Netherlands.The CompanyThe mission of the company is to serve patients. They provide the capabilities, resources and rewards of a global enterprise, while maintaining the entrepreneurial-ism and pioneering spirit that marked our early days as a biotechnology innovator. Encouraging the team members to have fulfilling and meaningful careers through challenging assignments, career development and valuable opportunities such as this one.

Role DescriptionAs a Technical QA Specialist you will report to the Senior Manager QA. The technical QA team consists of 5 people within an organization consisting of 45 people.
Together with the team you will keep oversight on introduction and modification of equipment, information systems and packaging configurations for commercial secondary packaging operations. By controlling the critical aspect of the operations and systems throughout the life cycle, you will be safeguarding the high quality of the medicines. Together with the team you will provide quality engineering support for quality investigations and testing strategies.

Your role will be the liaison between quality and engineering to ensure new equipment is introduced within manufacturing conforming quality quidelines. You will work closely together in different project teams with the following departments: Process Development (PD), Maintenance and Engineering (M&E), Production, Information Systems (IS) located both on site and internationally.

Responsibilities- Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment and information systems in cooperation with the other departments
- Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements by reviewing and approving validation documentation
- Provide support to Plant QA regarding equipment or information system related production issues. You provide quality engineering support to establish appropriate sampling plans and acceptance criteria
- Project team member to develop efficient quality processes and translate them in standard operating procedures
- Perform final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record

Requirements- Master degree in engineering or pharma
- Minimum of 5 years experience with equipment and automation validation
- Relevant experience with equipment and automation validation
- Knowledge of the Quality Assurance principles;
- Able to work on a wide variety of projects simultaneously;
- Able to work in a changing environment;
- Fluent in English.


- Engineering or pharma background and a high level of quality awareness
- Able to manage complex projects and work closely together with a wide variety of people within the company
- 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

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

Do you have a background in engineering or pharma and a high level of quality awareness, able to manage complex projects and work closely together with a wide variety of people within the company, maintain oversight on different projects and dive into details when required?

Then become a part of this close team within a large international company and contact me!

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

 

Aanbod/arbeidsvoorwaarden
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Samenvatting

Plaatsingsdatum :
29/03/2019
Referentienummer :
97980
Standplaats :
-
Adres :
-
Postcode :
9723 HK
Opleidingsniveau :
WO
Uren :
Nader te bepalen
Dienstverband :
Vast
Werkervaring :
5 - 10 jaar
Contactgegevens :
bekijk