MAIN ACCOUNTABILITIES AND DUTIES
Operational quality management of a dedicated product portfolio which includes:
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Quality management of deviation and complaint records and their related CAPAs
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Assessment and management of change controls
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Edition of QA Agreements with Zentiva third parties and subcontractors
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Collection and evaluation of PQRs and stability data
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Compliance evaluation of Third Parties and products
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Maintenance of product database
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Collection and review of CoA/CoC
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QA support of product launches and transfers
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GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations
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Prepare audit and audit plans
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Conduct and participate to external audits
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Evaluation of audit reports
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Participate to internal audits and inspections
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KPI monitoring and reporting
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Other tasks may be performed under the direction of the Manager within the agreed type and scope of work.
OTHER RESPONSIBILITIES
QUALITY
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Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.
HSE
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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
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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
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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
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University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
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Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment
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Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
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Management of subcontractors is an advantage
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Proven track record of project management skills
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Strong communication skills and negotiation strength
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Proactive attitude
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Problem solving skills
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Hands-on attitude, flexible and open minded
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Collaborative and team-spirited
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Knowledge of IT tools
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Language - English: Advanced level
