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Qualified Person (Quality & Regulatory Compliance Expert)

Świdnica Stała Zobacz opis stanowiska
For one of our Clients, we are currently seeking a Qualified Person (QP) to join a two-person QP team within the Quality Department. This is a newly created position driven by the company's ongoing growth and expansion of the quality function.

Dodano 07/08/2026

  • 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



Kontakt
Marta Kozak
Numer referencyjny
JN-082026-7076941

Szczegóły oferty

Sektor
Inżynieria i produkcja
Obszar
Inżynieria jakości
Branża
FMCG (Fast Moving Consumer Goods)
Lokalizacja
Świdnica
Rodzaj umowy
Stała
Twoja aplikacja trafi do
Marta Kozak
Numer referencyjny
JN-082026-7076941