Requirements: English
Company: Chemo
Region: Azuqueca de Henares , Castilla-La Mancha
In a few words
Position : Stability R&D Coordinator
Location : Azuqueca de Henares (Guadalajara)
Experience : 3-4 years
Want to know more?
INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.
The activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.
Ready to be a #Challenger?
What are we looking for?
We are incorporating a new INSUDER as Stability R&D Coordinator to join the R&D team at our plant in Azuqueca de Henares.
The challenge!
- Anticipate for laboratory material needs and equipment required.
- Stability Database and stability chambers manteinance
- Provide technical support to the team.
- Approve Stability Protocols and general stability documentation.
- Investigate Out Of Specifications and Out of Trend results (OOS and OOT), significant changes and anomalous results and approve the documentation associated with them in a timely manner
- Lead investigations to find the root cause of OOS and OOT and propose CAPAs in collaboration with QA
- Write the stability reports to established retest dates and temperature restrictions when neccesary
- Write change controls and SOPs related stability studies
- Advise on the recruitment process of laboratory analysts to assess the technical knowledge of the candidates.
- Be aware and constantly review of regulatory guidances that apply to the stability testing
What do you need?
- Education: Degree in Chemistry.
- Languages: Fluent Spanish and English
- Experience (years/area): 3-5 years of experience in Pharma industry in a similar position.
- Specific Knowledge: ICHs, pharmacopoeia EP and USP and GMP regulations.
- Travels: if required.
- Personal skills: good communication skills, customer-oriented, proactivity, Organizational skills.
Our benefits!
- Flexible start time from Monday to Friday (full-time).
- Permanent contract.
- Attractive salary package.
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