QA Specialist

Kelix Bio Malta is a leading pharmaceutical manufacturing company specialising in sterile injectable finished dosage forms (FDFs) for oncology treatments. As an FDA- and EMA-approved manufacturing facility, we are committed to the highest standards of quality, compliance, and patient safety. Our facility is dedicated to the development and manufacture of liquid and lyophilised sterile pharmaceutical products, serving both local and international markets.

Driven by a passion for excellence, we combine advanced manufacturing capabilities, robust quality systems, and a highly skilled workforce to ensure the reliable supply of high-quality medicines. 

As we continue to grow, we are seeking a dedicated QA Specialist to join our Quality Assurance team and contribute to maintaining the highest standards of product quality, patient safety, and regulatory compliance.

QA Specialist

Are you passionate about quality, compliance, and continuous improvement within the pharmaceutical industry? We are seeking a QA Specialist to join our Quality Assurance team and play a key role in maintaining and enhancing our Quality Management System (QMS) while ensuring compliance with GMP and regulatory requirements.

Key Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS).

• Review and approve quality documentation, including batch manufacturing and packaging records.

• Support investigations related to deviations, non-conformances, complaints, and out-of-specification results.

• Participate in the implementation and effectiveness monitoring of Corrective and Preventive Actions (CAPAs).

• Contribute to validation activities and Product Quality Reviews (PQRs).

• Provide Quality Assurance oversight and support to manufacturing, packaging, warehouse, and laboratory operations.

• Ensure the consistent application of GMP standards and quality requirements across the site.

• Support batch disposition and Qualified Person (QP) release activities, as applicable.

• Assist in monitoring quality metrics and key performance indicators (KPIs).

• Support training initiatives and help foster a strong culture of quality and compliance.

• Collaborate with cross-functional teams to drive operational excellence and continuous improvement.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Life Sciences, Biology, Chemistry, Biotechnology, or a related scientific discipline.

• Good understanding of GMP requirements and pharmaceutical quality systems.

• Strong attention to detail with excellent organisational and documentation skills.

• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, Outlook, and Visio.

• Business-level proficiency in English, both written and spoken.

• Strong problem-solving, communication, and interpersonal skills.

Preferred

• Previous experience in a Quality Assurance role and / or QC Microbiology role within the pharmaceutical industry.

• Experience with investigations, CAPA management, change control, validation, or batch record review.

• Knowledge of EU GMP requirements and regulatory expectations.