Amgen QA Manager in Sofia, Bulgaria

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. As part of its global expansion strategy, Amgen is seeking to appoint a well-qualified and experienced individual to assume the role of Quality Manager located in Sofia.

JOB SUMMARY

Quality Professional with background and experience supporting all Quality tasks related to distribution of commercial medicinal products.

Will fulfill the role of Quality of Amgen Bulgaria and support Amgen in all quality matters related to products imported and distributed in Bulgaria.

  • Monitor and communicate site performances in means of quality metrics to Amgen.

  • Supports regulatory GDP inspections by Bulgarian Drug Agency and Regional Health Inspectorate and other interactions with local Authorities.

  • Maintains quality systems at Amgen Bulgaria affiliate, Support investigations/deviation reports and nonconformance.

  • Supports other countries in North&East EU Region, as required

  • Acts as a back up to the Responsible Pharmacist

  • Acts as a advisor to the Responsible Pharmacist for Quality matters

  • Domestic and International travel will be required

Basic Qualifications

Degree in Chemistry, Pharmacy, Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Engineering (or Technology) and Biology or related technological field

Fluency in Bulgarian and English languages.

Preferred Qualifications

  • 3 or more years of relevant work experience within the pharmaceutical industry, preferably - experience with biologics, vaccines.

  • Must have strong knowledge and understanding of GDP requirements, cold chain transportation and storage, local regulatory requirements.

  • Experience in regulatory inspections

  • Experience in pharmaceutical equipment qualification, risk assessments, change control

  • Experience in providing support, troubleshooting unit operations, and resolving and documenting investigations to support GDP tasks.

  • Good communication skills (Bulgarian and English) technical writing and verbal communication/presentation

  • Interacts effectively with variety of communication and working styles and teams

  • Interact effectively with cross functional team

  • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality