Senior Qualified Person - GDP & Regulatory QA

Dr. Reddy's Laboratories; Cambridge; Vor Ort; GBP 65.000 - 90.000; Vollzeit

Zusammenfassung

Dr. Reddy's Laboratories in Cambridge, UK seeks a Responsible Person (RP) in Quality Assurance to ensure GDP compliance for import, storage, transport, and distribution of medicinal products. Reports to Head of Quality - UK and based onsite in Cambridge.

The RP oversees GDP training, QMS implementation, recalls, CAPA, and 24/7 transport-related issue management, ensuring regulatory adherence and licence maintenance.

Qualifikationen

• Master degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field.
• Eligible to act as a Qualified Person under UK/EU regulations.
• Significant Quality Assurance experience in pharmaceutical industry.

Aufgaben

• Maintain GDP Quality Management System and related documentation.
• Be accountable for products manufactured in Europe and stored/transported under the WDA.
• Ensure compliance to obtain and maintain the distribution licence.
• Provide GDP training and keep staff updated on regulatory requirements.
• Oversee product recalls and CAPA management.
• Manage 24/7 transport-related issues and supplier approvals.

Ausbildung

Master degree in Pharmacy/Life Sciences/Pharmaceutical Chemistry

Eligible to act as Qualified Person (UK/EU)

Significant Quality Assurance experience

Jobbeschreibung

Dr. Reddy's Laboratories in Cambridge, UK seeks a Responsible Person (RP) in Quality Assurance to ensure GDP compliance for import, storage, transport, and distribution of medicinal products. Reports to Head of Quality - UK and based onsite in Cambridge.

The RP oversees GDP training, QMS implementation, recalls, CAPA, and 24/7 transport-related issue management, ensuring regulatory adherence and licence maintenance.