FTC- Jr. Quality Assurance Specialist ESO

Job Summary

Job Posting Title- FTC- Jr. Quality Assurance Specialist ESO

Required qualifications, experience & skills

• University degree in technology, biological science, pharmacy or other health related discipline preferred
• Experience with quality systems such as GMP, GDP, ISO, MDR, or HACCP; cooperation with external subcontractors is advantageous; knowledge and active usage of IT tools
• Strong communication skills
• Proactive attitude
• Problem solving skills
• Self-reliance

Mission statement

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

Main accountabilities and duties

• Operational skills 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; external audits in line with valid audit plan of CMOs. Participation in internal inspections; Audit report evaluation
• Conducting a quarter review of performed activities (including evaluation of achieving and progress of key indicators)
• Participation on delegated project
• 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.
• Health, Safety and Environmental Management: Adheres to the principles communicated within the ESMS Policy of Zentiva and its internal rules for observing 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 of 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 herself/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

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