QP Trainee

Client and role summary: I am currently partnered with a Pharmaceutical Manufacturer in Munich area to recruit a QP trainee.

Your Tasks:

• Serve as a qualified person in line with §15 and §19 AMG, making critical decisions for the usage of market and clinical investigational products.
• Handle the evaluation of quality incidents, including the execution of follow-up actions such as notifying authorities and initiating market recalls.
• Ensure compliance with legal and regulatory standards, actively participating in inspections, audits, and self-assessments, including the evaluation of suppliers and service providers.
• Engage in the investigation and resolution of quality issues, such as out-of-specification results, deviations, and change controls, including the management of pharmaceutical quality complaints and corrective and preventive actions (CAPAs).
• 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.

Our Requirements:

• 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.
• Strong communication skills, teamwork orientation, and a structured, responsible approach to work, alongside a high commitment to quality, solution-oriented actions, and collaborative efficiency.
• An entrepreneurial spirit with a cross-functional mindset, comfortable with assuming responsibility and proficient in MS Office and SAP applications.
• Fluency in German & English

Application process:

CV and the references to my email: y.cakmak@sciproglobal.de

Call with a presentation of the company

I am your contact person for the entire application process (interviews to contract negotiations) i.e. You don't have to apply yourself

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