- Preparing, reviewing and approving protocols and Certificate of Analysis (CoA's) independently as per global requirements and harmonizing the process(es) across sites.
- Working together with both internal and external labs or a specific department to certify and re-certify new and already existing and certified reference standards.
- Initiating and handling quality events via the client specific quality/deviation management system (COMET).
- Interpreting and evaluating the data generated from the investigational analysis.
- Implementing corrective actions defined in quality records or Environment, Health and Safety (EHS) procedures.
- Interpreting temperature excursions during shipment of reference standards.
- Supporting questions from internal and external filings.
- Interpreting the regulatory guidelines for quality and EHS and ensuring their compliance.
- Maintaining the stock of RS
- A master's degree in a scientific related field or equivalent through experience.
- Experience with and exposure to pharmaceutical lab activities.
- Previous experience in a cGxP/cGMP environment is an asset.
- Previous experience in Project Management, Problem Solving or Change Management is an asset.
- Strong written and verbal communication skills in English.
- An enthusiastic and motivated person with the ability to be a great team player.
- A proactive approach, adaptive/flexible and a sense of urgency attitude.
- Fast-learning, accurate and not scared of taking ownership/responsibility.
- Good knowledge of Microsoft Excel, Word, PowerPoint and Outlook.
- A full-time (40hours/week) Monday – Friday job.
- A Permanent contract with flexible working hours.
- The ability to work 4 days from home and 1 day from the office (in Beerse Belgium).
- Easily reachable by public transportation from central station Antwerp (415/416/417).
- Work in a fast-growing international organization.
- Meal Vouchers 8 Euro/Working Day.
- Eco-Cheques +/- 250 Euro/Year.
- DKV Hospitalization insurance.
- Additional 12 ADV days per year.
- A company well-being program targeting both mental and physical well-being.
- A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment
- Personal development through learning on the job and additional trainings.
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Project Owner - Beerse, België - Eurofins
Beschrijving
Job Description
Reference Standards Project Owner
As a Reference Standards Project Owner, you will be working with a dedicated service team to provide services in the Small Molecules (SM) Reference Standards (RS) department. You will be:
Qualifications
Additional Information
