MISSION STATEMENT
To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor.
MAIN ACCOUNTABILITIES AND DUTIES
Operational skills
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
Auditing
- 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.
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
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What We Do
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
