GMP Quality Assurance Specialist - Batch Release & QMS

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 batch certification and GMP compliance in the East region. You will manage quality documentation, assist with QMS processes, and coordinate training and audits across the site.

The role requires a pharmacy-oriented education, 2+ years in pharma QA/QC, and strong English communication. You will collaborate with cross-functional teams to ensure regulatory alignment and robust quality controls.

Qualifications

• Higher education in pharmacy or related field is required.
• 2 years of experience in pharmaceutical manufacturing QA or QC.
• At least 3 years in a similar QA position within a pharma company.
• Excellent written and spoken English.
• Strong commitment, responsibility and proactive task handling.
• Team collaboration skills and MS Office proficiency.
• Solid knowledge of quality systems, GMP regulations and compliance.
• Experience providing technical advice for Technical Agreements.

Responsibilities

• Support batch certification activities in line with GMP and local law.
• Ensure QC/QA documentation is current and GMP/GDP compliant.
• Manage quality documentation and QMS-related tasks.
• Support maintenance of Quality Management System (change control, deviations, CAPA, recalls).
• Prepare and update Quality Agreements for GMP activities.
• Use QA tools to monitor and control the QMS.
• Oversee administrative batch release in the computerized system.
• Oversee sample collection and handling.
• Update training matrix and coordinate training across departments.
• Manage test and reference samples.
• Handle product quality complaints (PQC) for the region.
• Coordinate Product Quality Reviews (PQRs).
• Support audits/inspections by authorities or notified bodies.
• Maintain compliance with region-specific regulations and guidelines.
• Conduct internal and external audits.

Skills

MS Office

GMP knowledge

Quality documentation

QA/QC experience

English (writing/speaking)

Audit support

Training coordination

Education

Higher education, pharmacy preferred

Job description

Accord Healthcare in Poland seeks a QA/QC professional to support batch certification and GMP compliance in the East region. You will manage quality documentation, assist with QMS processes, and coordinate training and audits across the site.

The role requires a pharmacy-oriented education, 2+ years in pharma QA/QC, and strong English communication. You will collaborate with cross-functional teams to ensure regulatory alignment and robust quality controls.