ESO QA Specialist

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