Quality Assurance Specialist

Accord Healthcare; Pabianice; On-site; PLN 90,000 - 130,000; Full time

Job summary

Accord Healthcare in Poland seeks a QA/QC professional to support GMP batch certification and QA documentation. You will assist regional QP’s and maintain the Quality Management System, ensuring compliance with GMP/GDP and regulatory standards. Strong communication in English and prior audit exposure are required.

Responsibilities include training coordination, sample management, and preparing quality agreements for GMP activities, with focus on East Region operations.

Qualifications

• Excellent knowledge of quality systems and GMP procedures.
• Min. 2 years in pharmaceutical manufacturing QA or QC.
• Min. 3 years in a similar pharmaceutical role.
• Very good English communication, both written and spoken.

Responsibilities

• Support batch certification activities in line with GMP principles and local law.
• Ensure QC/QA documentation is up to date and compliant with GMP/GDP.
• Maintain quality documentation and support QMS (deviations, CAPA, recalls).
• Prepare Quality Agreements for GMP-related activities and monitor QA tools.
• Oversee administrative batch release in the system and sample management.
• Coordinate training and training documentation across the Eastern Region.
• Participate in internal and external audits and audits by authorities.

Skills

GMP knowledge

QA/QC experience

Regulatory knowledge

MS Office

English communication

Audits

Education

Pharmacy degree

Biology/Chemistry background

Job description

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;