Client:
Chemo
Location:
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
815852456613878169632460
Job Views:
5
Posted:
10.02.2025
Expiry Date:
27.03.2025
Job Description:
Global Responsibility
Collaborate with the Head of QA-R&D of Chemo to ensure the activities of the R&D Department comply with internal SOPs, GMP, and EMEA and FDA legislation.
Specific Responsibilities
1. Collaborate with the Head of QA-R&D in implementing and maintaining a Corporate Quality System in R&D compliant with GMP.
2. Write and review corporate procedures to standardize R&D Department activities and ensure their adaptation to Good Manufacturing Practices.
3. Review and approve documents generated by R&D (i.e., Analytical validations, master batch records, procedures, and analytical methods).
4. Review and approve executed batch records and analytical results of R&D before their release.
5. Issue and review R&D analytical specifications.
6. Perform internal and external audits.
7. Collaborate with the Head of QA-R&D in preparing for and attending client audits and Health Authorities inspections.
8. Issue and organize documentation sent from QA to RA for new submissions of MA and to respond to DL.
9. Collaborate in GMP training of R&D employees.
10. Train new hires in specific activities and functions of the position where you are an expert.
Innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, self-development, sense of urgency, and initiative are essential.
Requirements and Personal Skills
1. Education: Degree in Health Sciences (e.g., Chemistry, Pharmacy, Biology, or Medicine) with supplementary knowledge of Quality and GMP.
2. Languages: Fluent in Spanish and English; knowledge of other languages is an asset.
3. Experience: 2+ years in Quality Assurance with desirable experience in R&D.
4. Contract: Temporary (6-8 months).
5. Specific Knowledge: Quality procedures and GMP.
6. Travels: Not required, may occur occasionally.
COMMITMENT TO EQUAL OPPORTUNITIES
We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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