MISSION STATEMENT
The ESO Quality QA Specialist is responsible for the quality lifecycle management of an assigned subcontracted product portfolio and independent Quality Assurance oversight of assigned products and suppliers.
The role ensures compliance with applicable Quality Management System, GMP, GDP and regulatory requirements and supports audits, product lifecycle activities and quality decision-making.
MAIN ACCOUNTABILITIES AND DUTIES
- Operational quality management of an assigned product portfolio, including:
- Independently manage routine deviations, complaints and related CAPAs.
- Conduct Root Cause Analysis and follow up agreed corrective and preventive actions.
- Review and assess change controls and their Quality impact.
- Review GMP manufacturing documentation, analytical data, CoAs/CoCs and relevant batch documentation.
- Support batch release decisions through review of Quality documentation.
- Collect and independently review PQRs and stability data.
- Conduct routine Quality Risk Assessments.
- Review qualification and validation protocols and reports.
- Assess compliance of assigned third parties, suppliers and products.
- Review supplier Quality documentation and support supplier Quality management activities.
- Prepare and maintain Quality Agreements with third parties and subcontractors.
- Identify potential Data Integrity risks and escalate where appropriate.
- Provide QA support for product launches, transfers and lifecycle activities.
- Apply GMP, GDP, ICH and other applicable regulatory requirements independently.
- Prepare for and participate in external supplier audits, internal audits and inspections.
- Review audit reports and follow up agreed actions.
- Monitor Quality KPIs, analyse relevant data and support Quality decisions.
- Maintain product and Quality databases and use applicable QMS systems independently.
- Communicate effectively across functions and with external partners.
- Manage routine Quality discussions and negotiations with suppliers.
- Support onboarding, training and knowledge sharing within the team.
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 5 years of relevant experience in Quality Assurance or a GMP-regulated environment.
- Strong knowledge of GMP requirements and good understanding of ICH and pharmaceutical regulatory requirements.
- Experience with deviations, CAPA, Root Cause Analysis, change control and Quality Risk Management.
- Experience reviewing GMP, analytical, stability and Quality documentation.
- Experience with supplier Quality management and audits is an advantage.
- Ability to work independently and apply Quality requirements in day-to-day decision-making.
- Strong communication and negotiation skills.
- Good analytical, problem-solving and data interpretation skills.
- Proactive, hands-on and collaborative approach.
- Good knowledge of relevant IT and Quality systems.
- English: Advanced level.
