Qualified Person (Quality & Regulatory Compliance Expert)

• International company from FMCG industry
• On-site

O naszym kliencie

Our Client is a well-known production company from FMCG industry located in Świdnica.

Opis stanowiska

• Certify and release medical product batches in compliance with GMP, Pharmaceutical Law, and Marketing Authorisations.
• Support the development and maintenance of the Pharmaceutical Quality System (PQS).
• Lead investigations of deviations, OOS results, and quality complaints.
• Conduct quality risk assessments and implement risk mitigation measures.
• Make decisions regarding product recalls, market suspension, or withdrawal, liaising with regulatory authorities as required.
• Approve supplier qualifications and oversee audits of contract manufacturers.
• Ensure medical devices comply with MDR/IVDR requirements before market release.
• Maintain and oversee technical documentation and EU Declarations of Conformity.
• Ensure compliance with Post-Market Surveillance (PMS) obligations.
• Oversee vigilance activities, including reporting of serious incidents and Field Safety Corrective Actions (FSCA).

Profil kandydata

• Registered Qualified Person (QP) with the relevant regulatory authority.
• Degree in Pharmacy (preferred), Medicine, Veterinary Medicine, Chemistry, Biology, or a related scientific field.
• Minimum 1-2 years of relevant experience in pharmaceutical manufacturing or import operations.
• Strong understanding of GMP requirements and pharmaceutical quality systems.
• Clean criminal record as required by applicable regulations.
• Practical knowledge of GMP ISO 13485, and FDA regulations.
• Very goog English command
• Strong decision-making skills, accountability, and resilience under pressure.
• Excellent organizational and documentation management skills.
• Analytical mindset with experience in Root Cause Analysis and CAPA methodologies.

Oferujemy

• Direct collaboration with senior leadership, regulatory authorities, notified bodies, and external partners.
• Exposure to both pharmaceutical and medical device industries, enabling broad professional development.
• Continuous professional development, training, and support in maintaining regulatory expertise.
• Compensation package aligned with experience and qualifications
• Flexible working arrangements and a collaborative, quality-focused culture.
• Private Medical Care
• Possibility to have HO once per week