Technological Transfer Technician

hace 7 días

Barcelona, España BLOCKCHAINPHARMA SOLUTIONS SL A tiempo completo

Our client is an international Pharmaceutical and API Manufacturer, and we are looking for a technician with experience in manufacturing process technology transfer. The main tasks will be:

- Transfer of Manufacturing Process Technology.
- Attendance at product manufacturing at CMOs for follow-up and technical support, as well as involvement in the preparation/review of the corresponding manufacturing documentation.
- Commercial product lifecycle activities include: resolving manufacturing incidents, investigating out-of-specifications, and preparing the corresponding quality documents (e.g. change controls, deviations, CAPAs, etc.).
- Create Continuous Process Validation Reports for commercial products (CPV).
- Assist the regulatory affairs department in the production of related documents, dossier submissions to new markets, and response to Deficiency letters.
- Manage the Extractables and Leachables studies in the liquid formulation development phase with external CROs.
- Keeping the department's SOPs up to date.
- Manage the external studies required to adapt registration dossiers to new markets/countries.
- Assisting with Quality Assurance department in customer/CMO audits or requests.

We are looking for someone that has:

- University Degree in Chemistry, Biology, Pharmacy or similar.
- Experience in statistic software is highly desirable. Also any education related will be a plus.
- At least 3 years’ experience in R&D, Manufacturing, QA, etc.
- Fluency in spoken and written English (C1 or equivalent).
- Able to work in a team environment and to travel abroad few days a year.
- We are looking for a motivated and proactive person, able to take responsibilities,

results oriented and with an attitude that reflects our Company Values.

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