QP Trainee refers to a person who is undergoing training to become a Qualified Person. A Qualified Person is a professional who is responsible for ensuring that pharmaceutical products are manufactured, tested, and released in compliance with regulatory requirements - Shonto, United States - Quantum Innovations

Quantum Innovations
Quantum Innovations
Verified Company
Shonto, United States

3 weeks ago

Meredith Sinclair

Posted by:

Meredith Sinclair

beBee Recruiter
Description

Client and role summary: We are currently working with a pharmaceutical manufacturer in the Munich area to find a QP trainee.

Your tasks:

  • Act as a qualified person in accordance with §15 and §19 AMG, making critical decisions regarding the use of market and clinical investigational products.
  • Handle the evaluation of quality incidents, including taking necessary follow-up actions such as notifying authorities and initiating market recalls.
  • Ensure compliance with legal and regulatory standards by actively participating in inspections, audits, and self-assessments, including evaluating suppliers and service providers.
  • Investigate and resolve quality issues, such as out-of-specification results, deviations, and change controls, and manage pharmaceutical quality complaints and corrective and preventive actions (CAPAs).
  • Review and approve 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 considered 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
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