Senior QA Specialist ESO

Zentiva

Prague, Czech Republic

The ESO Quality Senior Specialist is responsible for the full quality lifecycle management of an assigned product portfolio and independent Quality Assurance oversight of external suppliers.

The role leads complex quality topics, identifies and manages quality risks, drives improvements within the Quality Management System, and acts as a senior Quality expert for internal and external stakeholders.

MAIN ACCOUNTABILITIES AND DUTIES

Manage Quality oversight of assigned products, external manufacturers and suppliers.
Lead complex deviations, complaints, Root Cause Analysis and CAPA effectiveness reviews.
Assess and manage change controls and significant quality risks.
Review manufacturing, analytical, stability and Product Quality Review documentation and identify trends or systemic issues.
Support batch disposition decisions by evaluating complex Quality risks.
Lead supplier quality assessments, Quality Agreements and improvement activities.
Lead and participate in supplier audits and inspection readiness activities.
Review qualification and validation documentation and challenge strategies and risk assessments where required.
Ensure compliance with GMP, GDP, ICH and applicable regulatory requirements.
Identify Data Integrity risks and drive appropriate corrective actions.
Perform Quality trend analysis, monitor KPIs and drive continuous improvement.
Provide Quality support for product launches, transfers and lifecycle activities.
Lead complex Quality discussions, negotiations and escalations with suppliers and stakeholders.
Act as Subject Matter Expert, provide guidance to colleagues and support capability development within the team.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

University degree in Pharmacy, Chemistry, Biology or relevant Life Science.
Minimum 6 years of relevant experience in Quality Assurance or a GMP-regulated pharmaceutical environment.
Experience and knowledge in sterile manufacturing at plant level is preferred.
Strong knowledge of GMP, ICH and pharmaceutical regulatory requirements.
Strong experience with deviations, CAPA, Root Cause Analysis, change control and Quality Risk Management.
Experience in supplier quality management, audits and external manufacturing is preferred.
Ability to interpret complex Quality data, identify trends and drive improvements.
Strong communication, influencing and negotiation skills.
Ability to manage complex discussions and escalations independently.
High level of autonomy, accountability and sound Quality judgement.
Strong analytical and problem-solving skills.
Proactive, collaborative and solution-oriented approach.
Ability to coach others and act as Subject Matter Expert.
English: Advanced level.