QA Specialist

Job Description

Dipharma SA is a successful company made up of dynamic, experienced, and proactive people who share the same values and strongly believe they are doing something meaningful for patients and for the community. We are committed to providing access to affordable and potentially improved generic medicines for patients affected by rare metabolic disorders.

To maintain the Company Quality System up to date and ensure a high level of GMP and GDP compliance, we are looking for a motivated and quality-oriented QA Specialist 100% with experience in the pharmaceutical industry to support and ensure compliance with European and international GMP regulations. The candidate will actively contribute to the maintenance and improvement of the Quality System in line with ICH Q10.

The candidate will contribute to the maintenance and improvement of the Quality System, ensuring compliance with EU GMP regulations and supporting the production of products with high therapeutic value, often characterized by small batches and high management complexity.

Key Responsibilities

• Management and review of deviations, OOS/OOT, and complaints


• Conducting investigations and defining root cause analyses


• Definition, implementation, and monitoring of CAPA


• Support for Change Control activities


• Execution of risk assessments according to ICH Q9


• Review and approval of GMP documentation, including SOPs, batch records, protocols, and reports


• Support in the management of low-volume, high-variability batches typical of medicines for rare diseases


• Support during internal and external audits, including regulatory authority and customer audits


• Cross-functional collaboration with Production, QC, and Supply Chain


• Monitoring of quality KPIs and promotion of continuous improvement

Requirements

• Degree in scientific disciplines, such as Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology, or related fields


• 3–5 years of experience in Quality Assurance within the pharmaceutical industry


• Experience in oral solid dosage manufacturing environments is preferred


• In-depth knowledge of EU GMP; familiarity with FDA 21 CFR 210/211 is preferred


• Experience in the management of deviations, CAPA, and change control


• Familiarity with Quality Risk Management approaches, according to ICH Q9


• Good investigation and problem-solving skills


• Excellent organizational and communication skills


• Good knowledge of English, both written and spoken

Preferred Skills

• Experience with orphan drugs / rare disease products


• Knowledge of typical oral solid dosage processes, such as granulation, compression, and coating


• Knowledge of electronic quality systems, such as TrackWise, Adiuto, etc.


• Experience with audits and regulatory inspections

We Offer

• A highly specialized environment in the field of oral solid dosage forms intended for the treatment of rare diseases


• Direct involvement in productions with a high clinical impact


• Professional growth opportunities within QA


• A dynamic environment with a strong focus on quality and compliance