QA Specialist ESO

MISSION STATEMENT

To do quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor.

MAIN ACCOUNTABILITIES AND DUTIES

Operational skills

Operational for dedicated product portfolio - Deviation execution, Complaint execution, Risk execution, QA agreement creation, QA POs executions Fiori, PQRs and Stability collection and evaluation, Portfolio compliance revision, CAPA execution, Out of stock participation, Change control assessment, Product database maintenance (TRW), CoA/CoC collection, QA support of launches and transfers.

QA GMP, GDP, MDR, HACCP, Food Supplement and Cosmetics Regulations systems

Legislation and process trainings, personal file maintenance.

Audits

Audit plan preparation.

To do the external audits in line with valid audit plan of CMOs.

Participation on internal inspections.

Audit report evaluation.

Conducting a quarter review of performed activities (including evaluation of achieving and progress of key indicators).

The employee will perform other tasks under the direction of the Manager within the agreed type of work.

Required qualifications, experience & skills:

University Degree in technology, biological science, pharmacy or other health related discipline preferred.

Experience with quality systems as GMP/GDP, or ISO/HACCP, or MDR, or HACCP and cooperation with external subcontractors is advantage, Knowledge and active usage of IT tools.

Strong communication skills.

Proactive attitude.

Problem solving skills.

Language - English: Advanced level.

R2466435