QP/Trainee QP - München, Deutschland - SciPro

Beschreibung

Serve as a qualified person in line with §15 and §19 AMG, making critical decisions for the usage of market and clinical investigational products.

Ensure compliance with legal and regulatory standards, actively participating in inspections, audits, and self-assessments, including the evaluation of suppliers and service providers.

Review and endorse process validations, product quality reviews (PQRs), manufacturing, and packaging instructions, and contribute to training and continuous education within the quality assurance framework.

A completed university degree in pharmacy, with additional certification as a competent person according to §15 AMG seen as a significant advantage.

At least two years of professional experience in the pharmaceutical industry, with a minimum of one year in pharmaceutical quality control in a §13 AMG accredited company.

Extensive knowledge of GMP and pharmaceutical legislation, including guidelines from national, EU, and international bodies like ICH, WHO, PIC/S, and the US FDA.

An entrepreneurial spirit with a cross-functional mindset, comfortable with assuming responsibility and proficient in MS Office and SAP applications.