Job Description

For our client, a global pharmaceutical company, we search for experts in the qualification of products and the process validation of active pharmaceutical ingredients (APIs). The aim is to guarantee a constant quality of the raw materials and to ensure that the external partner operates within the agreed-upon GMP policies and procedures. Furthermore, you will be the
Quality liaison between the external partner and the internal company personnel. This position is based in India.

Tasks

• Reporting to the Unit of the Associate Director and is a member of the Quality External Manufacturing team
• Audit to determine suppliers to be selected for the restructuring program
• Reviews and approves process validations and equipment qualifications as needed to support multiple product transfers
• Ensures the Quality Agreements are kept up to date and ensures review of the Quality elements in the Commercial Agreement.
• Conducts regular site visits to support training and coaching to initiate quality improvements
• Support technology transfer projects for the relevant suppliers Assures guidance is provided to the partner in the preparation of quality systems, procedures, and guidelines as applicable

Requirements

• BacheloraEUR(TM)s degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or equivalent
• 6 to 8 years experience in the industry
• Expertise and broad experience in Quality Systems, Quality Assurance and Quality Control
• Experience in Quality Assurance within a manufacturing environment
• An EU/FDA, API, Drug Product, Medical Device or equivalent environment experience
• Experience performing audits of external and internal manufacturers and testing laboratories
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines The ability to travel globally approximately 50% of the time

At HOX you can be sure that your CV will be understood and that you will be recognized as an individual. Our motto is: Scientists supporting Scientists.

With the combination of our own professional experience in the life sciences sector and comprehensive HR knowledge, we can be a competent and, above all, an honest partner in achieving your professional goals.

Please get in contact with me for further information. I am looking forward to hearing from you.

Yours sincerely

Ute Malzer-Funke