QA Specialist ESO

Пълно описание

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.