Senior QA Specialist ESO

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.

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