Main Accountabilities And Duties

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.

Other Responsibilities

QUALITY

Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE

Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations

COMPLIANCE

The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

Required Qualifications, Experience & Skills

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

ESO QA Specialist