Be a part of the winning culture!
At Zentiva, we are a team of 5.400 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.
Become part of Zentiva and be our new ESO QUALITY ASSURANCE SPECIALIST! Apply now!
Responsibilities
- Quality management of deviation and complaint records and their related CAPAs
- Assessment and management of change controls
- Edition of QA Agreements with Zentiva third parties and subcontractors
- Collection and evaluation of PQRs and stability data
- Compliance evaluation of Third Parties and products
- Maintenance of product database
- Collection and review of CoA/CoC
- QA support of product launches and transfers
- GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations
- Auditing. Prepare audit and audit plans
- KPI monitoring and reporting
We require
- University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
- Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment
- Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
- Management of subcontractors is an advantage
- Proven track record of project management skills
- Strong communication skills and negotiation strength, proactive attitude, problem solving skills, hands-on attitude, flexible and open minded, collaborative and team-spirited
- Language - English: advanced level, Bulgarian: native
- Advantage - External suppliers’ knowledge, management of external suppliers, regulatory background, auditing experience
What is in it for you
- An opportunity to work for a successful international pharmaceutical company.
- An opportunity to learn newest approaches in managing creative and highly adaptive business organizations.
- Pleasant and dynamic working environment.
- Continuous personal development.
- An attractive compensation & benefits package.
- Above standard social and benefit program.