QA Specialist

Accord Healthcare; Pabianice; Hybrid; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Holiday

Bonus

Pension scheme

Job summary

Accord Healthcare Europe is a leading pharmaceutical company, expanding its QA footprint in Europe. We seek a QA professional to support batch certification, ensure GMP compliance, and maintain the QMS across the Eastern Region.

The role involves audits, document control, and collaboration with cross-functional teams to ensure high-quality medicines reach patients worldwide. Excellent English and MS Office skills are required.

Qualifications

• Higher education (pharmacy preferred) or related field.
• 2+ years in pharmaceutical manufacturing, QA or QC.
• 3+ years in a similar role within a pharmaceutical company.

Responsibilities

• Support batch certification in line with GMP principles and local law.
• Ensure QC/QA documentation is up to date with GMP/GDP requirements.
• Manage quality documentation and QA processes across the Eastern Region.
• Maintain QMS: change control, deviations, CAPA, recalls.
• Prepare and update Quality Agreements for GMP activities.
• Monitor QA using QA tools and QMS.
• Oversee batch release and sample collection in the system.
• Coordinate training and maintain training records.
• Handle product quality complaints and PQRs.
• Support supplier and regulatory audits within the region.
• Ensure compliance with regulations and internal guidelines.

Skills

GMP knowledge

QA documentation

MS Office

English communication

Education

Pharmacy degree

Tools

QA tools

Job description

Select how often (in days) to receive an alert:

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

• Higher education (pharmacy preferred faculty), medical analytics, biology, biotechnology, chemistry, medicine, veterinary medicine)
• 2-year professional experience of working in a pharmaceutical manufacturing, Quality assurance or Control,
• 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
• Excellent Knowledge of current regulations for quality systems, GMP procedures and compliance;
• Experience in providing technical advice and support in the preparation of Technical Agreements to the Contracts and Proposals group;
• Internal and external audits experience

The Rewards

In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

A Bit About Us

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.

Footer

All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

If you would like to request this information in an alternative language, please get in contact with us on [e-mail]