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;