Global Quality Regulatory API Specialist
hace 2 semanas
Job Summary
Insud Pharma is seeking a highly skilled Global Quality Regulatory API Specialist to support the Global API Quality and Regulatory Director in evaluating current regulatory requirements for API CMOs and JVs sites.
Key Responsibilities:
Collect and review information from manufacturers, ensuring compliance with regulatory requirements from a chemistry and solid-state perspective.
Interact with manufacturing sites and authorities, providing technical support and expertise as needed.
Contribute to responding to queries from regulatory agencies and customers, providing technical expertise and guidance.
Support the development of strategies for responding to deficiency letters and customer technical requests.
Requirements:
University-level degree in Pharmacy, Chemistry, or a related Science discipline.
Fluent English and Spanish language skills.
2-5 years of experience in technical quality documentation in a regulated environment (GxP), preferably in chemistry and solid-state areas.
Personal Qualities:
Autonomy, precision, hands-on attitude, effective communication, and technical writing skills, with ability to interact with multicultural and international remote teams.
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