Responsible for operational quality management, auditing, KPI monitoring, compliance evaluations, and support during product launches for a dedicated product portfolio.
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
Top Skills
Gdp
Gmp
Haccp
It Tools
Mdr
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