Quality Assurance Specialist

Accord Healthcare; Pabianice; Vor Ort; PLN 70.000 - 110.000; Vollzeit

Zusammenfassung

Accord Healthcare is seeking a Quality Assurance Specialist in Pabianice, Poland, for a full-time permanent role. The position focuses on supporting QA and GMP batch certification, maintaining QMS alignment, and coordinating audits. Strong English communication and GMP knowledge are essential.

The role involves documentation management, deviation handling, CAPA support, and collaboration across departments to ensure timely batch releases in the East region.

Qualifikationen

• 2-year professional experience in pharmaceutical manufacturing, QA or control.

Aufgaben

• Support QA and GMP batch certification activities.
• Ensure QC/QA documentation compliance with GMP/GDP requirements.
• Maintain and manage quality documentation and QA tools.
• Support training matrix updates and cross-department coordination.
• Assist internal and external audits and regulatory compliance.

Kenntnisse

GMP knowledge

Quality systems

MS Office

English communication

Team collaboration

QA documentation

Ausbildung

Pharmacy degree

Jobbeschreibung

Quality Assurance Specialist

Role: Full-time, permanent

Location: Pabianice, Poland

Salary: Competitive + bonus + benefits

The Role

To support Quality assurance and control, including GMP aspect of batch certification. To support local QP’ in batch certification management to reduce expected release timelines. QA support in East region.

• Supporting batch certification activities in accordance with GMP principles and local pharmaceutical law (management of manufacturing site documentation / deviation management / temperature excursion report management).
• Ensuring that all QC/QA documentation is up to date and compliant with current GMP/GDP requirements.
• Managing quality documentation.
• Supporting the maintenance of the Quality Management System (change control, deviations, CAPA, recalls).
• Preparing and updating Quality Agreements for GMP-related activities.
• Using QA tools to monitor and control the QMS.
• Oversight and management of administrative batch release in the computerized system.
• Oversight and management of sample collection.
• Updating the training matrix and coordinating with all departments and new employees to ensure training and training documentation management within the Eastern Region.
• Managing test samples and reference samples.
• Handling product quality complaints (PQC) from the region.
• Coordinating and managing PQRs (Product Quality Reviews).
• Supporting audits/inspections conducted by competent authorities or notified bodies within the region.
• Maintaining compliance with applicable regulations, directives, and guidelines in the Eastern Region.
• Conducting internal and external audits.

The Person

• Excellent Knowledge of current regulations for quality systems, GMP procedures and compliance;
• 2-year professional experience of working in a pharmaceutical manufacturing, Quality assurance or Control;
• Higher education (pharmacy preferred faculty), medical analytics, biology, biotechnology, chemistry, medicine, veterinary medicine);
• Min. 3 years of experience working in a similar position in a pharmaceutical company;
• Very good communication in English in writing and speaking;
• Commitment, responsibility and an ambitious approach to tasks;
• Collaboration skills in a team;
• Very good knowledge of the MS Office package;
• Experience in providing technical advice and support in the preparation of Technical Agreements to the Contracts and Proposals group;
• Internal and external audits experience;