QA Specialist Eso Prague, Praha

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.
OTHER RESPONSIBILITIES
QUALITY
- Adheres to the principles of GMP, GDP, MDR, HACCP, Food Supplement and Cosmetics Regulations 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.
- Health checkup for presence in production and audit execution_._
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*
- ) country specific
- The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva "Code of Common Senses") and will comply with the principles stated therein and in all related policies and other internal documents.
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

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