Please update to one of the following browsers:
- Google Chrome
- Microsoft Edge
- Apple Safari
- Mozilla Firefox
You can find details about supported web browsershere.
QA Specialist- Leiden, Netherlands
- Full-time
Company Description
Eurofins PROXY is part of the internationally operating Eurofins Scientific. We are the largest Dutch GMP Quality Control laboratory for the pharmaceutical industry. Eurofins PROXY specializes in chemical and physical testing for (bio)pharmaceutical raw materials, intermediates and final products, and offers a very diverse package of analytical testing methods for national and international clients within the (bio)pharmaceutical industry.
Job Description
As QA Specialist you maintain a GMP compliant Quality Management System for the manufacturing and testing of raw materials and (biological) drug products based on applicable regulations and guidelines. You will have a diverse role in a high-paced environment, interacting with both our customers and internal staff.
Responsibilities:
- Investigating customer complaints and act as point of contact towards customers for Quality related matters;
- Review, assess and approve (complex) investigations related to deviations, non-conformances and out of specifications;
- Review and release of certificates of analysis, reports, materials, equipment and internal data;
- Review facility and environmental monitoring;
- Organize, host and support customer audits and regulatory inspections;
- Support and coordinate risk assessments;
- Review and approve batch records;
- Assist in maintenance and development of the QMS;
- Promote the awareness of quality, regulatory and customer requirements throughout the company;
- Lead and coordinate QA improvement projects;
- Act as deputy of the QA Manager.
Qualifications
- Bachelor or Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline;
- Minimum of 2 years of experience in a GMP environment;
- Preferably experience with facility qualification and release;
- Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH);
- Knowledge of biological process development and manufacturing is preferred;
- Organized work processes / set priorities;
- Strong decision making and problem-solving skills;
- Team player, able to work with all levels in the organization;
- Positive mind set;
- High level of integrity;
- Fast learner;
- Fluent in English, written and spoken.
Additional Information
Additional Information
PROXY and Eurofins: A world of possibilities
This position is based at Eurofins PROXY on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Eurofins PROXY also offers:
- A competitive salary;
- Flexible working hours;
- 25 days of vacation with the option to purchase 7 additional days (based on a fulltime contract);
- Travel allowance of 23 cents net per kilometer. Are you traveling by public transport? Then your travel expenses will be fully reimbursed via NS Business Card;
- Participation in a pension scheme with 50% contribution by Eurofins;
- Each month, you accumulate a choice budget balance of 8.25% of your gross salary. This includes, among other things, holiday pay and a year-end bonus. You can choose to have this amount paid out, or you can use it to buy extra days off, for example. You choose what suits you best;
- Discount on additional health insurance;
- Tax benefit via FiscFree when purchasing various products and services via your gross salary, such as a bicycle, sports contribution, fitness, mobile telephony, computers & tablets or a weekend away;
- Professional training and opportunities for training and development;
- Training options via the online learning platform Good Habitz.
Working at Eurofins PROXY offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees:
- Diverse developmental opportunities within the organization;
- A large client portfolio ensures a lot of diversity in your work.
More about Eurofins Scientific
Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.
In 2023, Eurofins generated 6.515 billion Euro proforma turnover in 900 laboratories across 62 countries, employing about 62.000 staff.
Acquisition for this vacancy is not appreciated.
QA Specialist
- Leiden, Netherlands
- Full-time