QA Specialist ESO София

QA Specialist ESO
София

At Zentiva, we are a team of 5, 000 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 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.


What Would Be Your Main Responsibilities



Operational quality management of a dedicated product portfolio which includes:

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

Conduct and participate to external audits

Evaluation of audit reports

Participate to internal audits and inspections

KPI monitoring and reporting

Other tasks may be performed under the direction of the Manager within the agreed type and scope of work.
We Need You To Have

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

Knowledge of IT tools

Language - English: Advanced level
It is crucial for us to have satisfied employees. Therefore, we can offer you the following:

Competitive salary;

Additional benefit package;

Hybrid mode of work;

International working environment and a passionate team of professionals;

Continuous Learning & Development opportunities.