ESO QA Specialist

MAIN ACCOUNTABILITIES AND DUTIES

Operational skills

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