GMP Compliance Specialist (Quality Assurance)
We are looking for a GMP Compliance Specialist (QA) for our R&D Division.
- Actively identify and manage technical problems and risks.
- DMF preparation and analytical validation.
- Good understanding of the Generic Industry at API level.
- Understanding of Marketing Authorization procedure.
- Degree in Chemistry or Pharmacy. PhD will be a plus. Master in Pharmaceutical Industry will be a plus.
- Experience in API Pharmaceutical industry: minimum 2 years.
- Experience in Regulatory Affairs Department and regulatory related fields desirable.
- Experience in very Technical positions.
- High knowledge in Analytical chemistry.
- High knowledge in GMP at Industrial level (ICH compliance and auditing).
- Minimum 2 years of experience in a similar position.
- Good interpersonal skills.
- Fluency in Spanish / mother tongue or negotiation level.
- Fluency in English / mother tongue or negotiation level.
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