Старший фахівець системи якості (фарма)

Acino part Arcera is an international pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

We are constantly expanding our market position and therefore, we are looking for a dedicated and motivated Senior QA Specialist to strengthen our Team.

Requirements to candidates:

• University degree in Pharmacy, Chemistry, Biotechnology, Biomedical Sciences, or a related field.
• Minimum 2 years of experience in Quality Assurance, Quality Control, Manufacturing, or pharmaceutical distribution.
• Knowledge of GMP/GDP requirements, pharmaceutical regulations, ICH guidelines, WHO standards, and EudraGMP.
• Good command of English (Intermediate level or higher).
• Experience working with computerized systems and documented quality processes.
• Strong analytical skills, attention to detail, accountability, and ability to manage multiple tasks simultaneously.

Nice to have:

• Experience with Electronic Quality Management Systems
• Knowledge of deviation, CAPA, change control, and complaint management processes.
• Experience participating in audits, self-inspections, and regulatory inspections.

Main responsibilities:

Lead the complaint handling process, including complaint intake, assessment, follow-up with manufacturing sites and business partners, tracking investigations, evaluation of root causes, implementation of corrective actions, and communication of outcomes to relevant stakeholders

• Coordinate and support deviation investigations, ensuring adequate impact and risk assessment, identification of root causes, definition of CAPAs, and verification of their effectiveness.
• Manage and coordinate quality events, CAPAs, and change controls, ensuring timely investigation, documentation, escalation, and closure in compliance with internal procedures and GxP requirements.
• Monitor quality metrics and trends related to complaints, deviations, and CAPAs, identify recurring issues, and support continuous improvement initiatives within the Pharmaceutical Quality System.
• Participate in internal audits, self-inspections, regulatory inspections, and follow-up activities.
• Collaborate with manufacturing sites, laboratories, regulatory affairs, pharmacovigilance, supply chain, and external partners to ensure compliance with applicable quality requirements.
• Prepare quality reports, metrics, and management reviews, and ensure timely escalation of critical quality issues

What we Offer:

• Official employment
• International experience and professional growth
• Working in a friendly, dynamic, supportive and diverse environment