Netherlands Job Openings
TMC
QC Specialist - Life Sciences department
Leiden
FULL TIME
August 11, 2024
- Technology & Engineering
- Energy & Renewables
- Life sciences & Pharma
- Digital & IT
About this vacancy
We are seeking a highly motivated QC specialist to join our Quality Control team. The QC team is mainly responsible for method transfer, training, and SME support to our decentralized manufacturing units (DMUs). Furthermore, the team is involved in the overall strategy on scaling our decentralized network, ensuring compliant and efficient processes to strengthen and enhance our model.In this role, the QC Specialist will be hands-on with QC SME support of clinical runs, quality record management, implementation of Changes, CAPAs and procedural updates and be a back-up for training of methods.
Responsibilities
- Clinical runs support as QC SME (troubleshooting and QC review);
- quality record management (Deviation, CAPAs and Change controls);
- write and review documentation related to QC;
- review and approve procedures;
- function as back-up for QC training if needed;
- collaborate cross-functionally to ensure that the processes are aligned and communicated;
- ensure improvements that are designed and implemented are compliant while keeping simple and efficient.
What we expect from you
The ideal candidate has a strong pharmaceutical background in Quality Control within an Good Manufacturing Practices (GMP) regulated environment.- BSc/MSc in life sciences, biotechnology, or related discipline;
- around 3-years’ experience in QC in the pharmaceutical / biotech industry;
- experience with quality record management and root-cause investigation;
- experience with various analytical techniques such as Flow Cytometry, PCR and cell-based assays is preferred;
- strong knowledge of GMP guidelines;
- strong interpersonal, verbal and written communication skills;
- ability to be flexible with changing priorities;
- self-driven and can-do mindset;
- combination of conceptual thinking with pragmatic approach to implementation;
- fluent in English.
What you can expect from us
- Challenge and variety: together, we will search for your first assignment and client, allowing you to explore new and challenging techniques, processes, and people;
- security: with a permanent contract at TMC, you will work for various clients that you choose yourself
- personal development: an experienced coach and a diverse range of training options are available to help you develop into the best version of yourself;
- professional development: a team of experienced professionals, several training courses and your personal Business Manager will help you further optimize your 'market value';
- fun & team: we offer interactive workshops, knowledge-sharing sessions and social events.
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