Job responsibilities

• Establishment and maintenance of quality management system, including governance, controls and documentation processes
• Leadership, development and management of regulatory and registration activities related to products under development and/or in production
• Ensuring that development and production processes have quality built into all processes and meet all internal and external requirements
• Collaboration with the purchasing function to establish quality requirements for external suppliers
• Identification of ways to reduce waste and increase efficiency, with a focus on quality control laboratories and quality assurance processes
• Support other functions in the RCI process and CAPA implementation, to ensure that potential non-conformities are appropriately addressed
• Establishment of training system for the company's employees' expertise, providing training, tools and techniques that enable the company to achieve quality standards
• Ensuring the company's products comply with GMP and customer requirements
• Advise other functions in the company and collaborate with customers on regulatory matters
• Conducting and manage regulatory reviews and inspections by governmental agencies and customers

What we expect

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

Our offer

• an employment relationship for an indefinite period with a trial 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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