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Curriculum Vitae - Sanja Peterlić, B.Sc. Medical Biochemistry, Senior Consultant and Auditor Print E-mail

Background

Sanja has more then 18 years of domestic and international experience in auditing, training and consultancy. Throughout her career, she has held a variety of positions ranging from Quality Control Engineer, Manager of Quality Assurance, Senior Quality System Specialist and Director of Quality. Working for public and private organizations, both manufacturing and service industries, she has extensive experience in Quality/Compliance management (FDA, EU and PIC/S Good Manufacturing Practice (GMP), Good laboratory practice (GLP) and Good Clinical Practice (GCP) standards), implementing comprehensive and effective quality system approach in pharmaceutical GMP, GLP and GCP, ISO 9001 (QMS), ISO 14001(EMS), ISO 22000 including HACCP and ISO 17025 systems, quality by design and risk management, delivering effective consultancy and training programs as well as conducting 3rd party audits all over the world.
Sanja is able to assess quickly an organization's needs and determine the appropriate tools and techniques needed to best assist her clients. She is skilled in auditing, source inspection and identifying areas for improvement in operations, processes and communications.

Specialties

Sanja has extensive knowledge on implementation and development of quality assurance system for finished pharmaceuticals, active pharmaceuticals ingredients (APIs) and medical devices. She has more then 10 years experience of regular auditing of quality system as well as auditing suppliers and contractors of finished pharmaceuticals, raw materials, primary and secondary packaging materials.
Sanja specializes in working with organizations seeking GMP, GLP or GCP compliance, FDA approval, ISO QMS and EMS implementation, documentation, internal auditing techniques and registration and approval of drugs, APIs and medical devices in USA, EU, Canada and Australia. She has been working in a variety of industries, some of which include: pharmaceutical, manufacturing, distribution, testing in laboratory with accreditation, government, healthcare, education, services, as well as not-for-profit. Sanja is able to train and interact with all levels of an organization, establish and motivate teams to process improvement, and lead company-wide programs that result in significant cost reduction. She is certified consultant by HAMAG (Croatian Agency for Small Business) and cooperates on project supported by BICRO (Business Innovation Centre of Croatia). She is fluent in both English and Czech and, as a frequent GMP Trainer and ISO Standards lecturer, presents series of programs in both languages.

Clients

For the past 10 years Sanja has been a quality specialist, consultant, trainer and auditor. She has been teaching auditors and has been holding implementation courses for thousands of students in GMP regulations and QMS standards. As Lead Consultant, she has also directed a number of companies toward successful FDA, EU GMP, PIC/S approvals, certification of ISO standards, laboratory accreditation, as well as CE marking. During Sanja’s career, she has assisted both small and large organizations in overall quality improvement efforts and in achieving compliance with GMP, GLP, GCP, QMS and EMS standards.

Credentials

Sanja received her BS in Medical Biochemistry at the Pharmaceutical-Biochemical Faculty in Zagreb, Croatia. She completed further education in area of GMP, GLP and GCP, ISO and HACCP on international courses and IRCA accredited training providers. Sanja is a Member of Croatian Society for Quality and Croatian Pharmaceutical Society, Croatian Society for Medical Biochemist, Association of Management Consultants, International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA) and Pharmaceutical Quality Group (PQG).