The candidate will join the Quality Control Laboratory, reporting to the Head of Analytical Services in collaboration with other QC section heads, technicians and analysts.
Job assigment:
• Implementation of Good Controlled documentation and GMP requirements for analytical methodologies, method transfer and Validation in order to fulfil the analytical requirements of our customers following the clinical development of the Drug Substance and Drug Product.
• Implementation of LIMS management
• Achieving the goals of each project by complying with the specific timelines agreed with our customers.
• Improving the GMP performance of the laboratory.
• Implementation of transfer and validation methodologies complying with existing regulatory requirements
• Control and Troubleshooting of OOS and deviation in the laboratory.
• Working closely with the analytical development team in order to transfer analytical methods internally.
• Working closely with our customers in order to transfer their analytical methods to the laboratory.
• Management of Validation of analytical methods according to ICH guidelines and GMP requirements depending on the intended use of the method.
• Management of the stability studies agreed with our customers in collaboration with other technician.
• Assure compliance with regulatory requirements for sample storage and retention samples.
Assessment criteria:
• 3-5 years of experience in the Pharmaceutical or preferably Biotechnological Industry in the field of Quality Control, under GMP environment.
• Practical experience and technical proficiency in analytical method transfer and method validation in QC departments
• Experience in managing and performing stability studies.
• Experience in working with LIMS
• Experience in the preparation of documentation (SOPs, Analytical Method Validation Protocols, Analytical Method Validation Reports,…).
• Proficiency at working within regulatory guidelines (EMA, FDA, ICH,…).
• BSc in Pharmacy/Chemistry/Biochemistry and/or equivalent. MSc and/or PhD is desired.
• Proven working experience in GMP or GLP environments.
• High level of English.

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