MAIN ACCOUNTABILITIES AND DUTIES
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
- 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
