Job responsibilities

• management and development of quality control processes to ensure efficiency and compliance with current regulations and for ensuring comprehensive customer service
• active participation in the creation and implementation of the quality system in the area of Quality Control laboratories
• designing and establishing procedures in the field of quality control, analytical methods and specifications
• ensuring that quality is built into all processes in the field of quality control and that processes meet all internal and external requirements
• following trends in the field of analytics and being responsible for the consistent and efficient operation of the quality control area
• coordinating interlaboratory standardization of laboratory equipment and providing a strategy and long-term plan for laboratory development, including PAT
• ensuring the correct implementation of out-of-specification, out-of-trend (OOS/OOT) results investigations, cooperating in the event of technical problems in laboratories
• supporting other functions in the process of incident investigation (RCI) and implementation of corrective actions (CAPA) to ensure that any non-conformities are appropriately addressed
• ensuring that all methods and equipment used in the provision of scientific information have the required accuracy and precision to support customer needs
• collaborating with the IT function to ensure appropriate system infrastructure and participation in the selection, approval and implementation of strategies for transferring QC analytics to clients
• leading the quality control team, providing routine training and feedback to team members and colleagues, in order to make the most of and achieve their maximum potential

What we expect

• University degree in pharmacy, chemistry, or other equivalent natural science degree
• Familiarity with regulatory framework for pharma industry, knowledge of EU, FDA and local regulations, ICH requirements and common quality standards for quality control laboratories
• experiences in GxP environment
• Advanced level of English

Our offer

• an employment relationship for an temporary period,
• a dynamic and stimulating work environment where we give priority to knowledge and professional competences,
• the possibility of actively co-shaping the company and introducing new ideas,
• the opportunity to acquire extremely important career knowledge and experience,
• a responsible position that offers excellent conditions for professional growth and career development in an international

Is this job a challenge for you? You are invited to submit an application at jobs@portonpharmatech.com

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