Validation & Transfer Technician

Encontrado en: beBee S ES - hace 4 semanas

Spain Galenicum Teletrabajo Freelance A tiempo completo

We are looking for a Validation & Transfer Technician to join our team in Esplugues de Llobregat. He/she will be in charge of following responsibilities.

Responsibilities:

Writing Protocols & Reports of analytical validation of new analytical methods for active pharmaceutical ingredient and finished dosage forms.Writing Protocols & Reports of transfers analytical methods between different Sites for active pharmaceutical ingredient and finished dosage forms.Management and review of the documentation provide by CRO’s and CMO’s in reference to the analytical validations & transfers activities.Management of all the material (such standards, samples of finish product, HPLC Columns,etc) needed to complete the activities. (Validations or Transfers)Follow-up of all the tasks that are carrying out.Collect external product methods of analysis current version and edit Galenicum MoA’s.Act as an interlocutor between the transferring laboratory and receiving laboratory.Writing of technical reports and SOP’s (Standards Operating Procedures).Propose improvement flows for the department.Technically guide the staff of whom in charge and provide answers and support to allow them to generate valuable results.Responsibility to replies to deficiency letters.Motivational skills to allow your team to achieve better results with time.Be focused on accomplishing the company goals.

Previous experience required:

Minimum 2-3 years’ experience in analytical development in GLP/GMP environment, showing proven experience in the development and/or validation of most of the following analytical methods: HPLC, UPLC, LC-MS, GC, UV-Vis, DSC, PSD, potentiometric titration, IR, KF Titration and Dissolution tests.Experience in writing and review Validation Protocols and Reports of Analytical Methods for different CRO’s or CMO’s.Very valuable to have knowledge of international guidelines EMEA, FDA, ICH, ANVISA and ISO.Experience MS Office

Education & Knowledge

Degree in health sciences preferably in Chemistry.Preferably Master’s degree in Analytical Chemistry Pharmaceutical Industry.Excellent level of English and Spanish, spoken and written.

Suitable Skills:

Self-sufficient, critical, disciplined, confident, hard working, creative, motivated, proactive, dynamic, methodical, organized and decisive.Strong analytical skills and problem solving.Highly responsible and capable to work under pressure to meet deadlines.Excellent organizational, planning and time management skills, to achieve project timelines.Detail oriented professional with good communication skills.Ability to prioritize multiple tasks and execute projects on time in a fast-paced environment.Ability to use and generate documentation in English.Ability to increase technical knowledge and apply new skills.