Teva Expert Principal MS & 

Bulgaria 

783326775

The main purpose of this role is to implement the strategy and to determine the methodology of for the validation of the production processes.

• Create the process validation strategies in accordance with the requirements of the company's policy for validation and maintenance of the validation status
• Participate in validation activities, by implementing harmonized corporate methods and validation documents, in order to achieve compliance with all GMP requirements of the regulatory agencies for which Dupnitsa is approved and certified for the export of medicinal products
• Execute tasks based on the corporate policies and on the basic and the standard operating procedures for validation
• Prepare or participate in the preparation and verification of the SOPs and the formats related to process validation activities
• Create the monitoring strategies
• Prepare risk assessment to determine the number of batches needed for the process validation
• Perform statistical analysis to assess the sustainability of the processes
• Participate in planned and unplanned inspections and customer audits
• Work on the material change
• Participate in activities related to Quality Improvement Programs (Product and Process Review) and other

• University degree preferably in Pharmacy, Chemistry or Biology
• Minimum of 3 years of experience in a pharmaceutical manufacturing and/or control of medicines environment
• Very good computer skills - MS Office
• Very good command in English language - written and verbal
• Proven skills in using statistical programs and/or performing statistical analyses
• Good understanding about the Law on Medicinal Products in Human Medicine, the regulatory requirements for the production of medicines in Bulgaria, the European and other international standards for Good Manufacturing Practice (GMP)
• Professional attitude and service orientation, to be a good team player
• Excellent time management skills

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Additional benefits according to the company policy
• Opportunity for future career development

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