Junior Qualified Person

Quality Assurance Manager / Junior Qualified Person

The company

For a strong international organization in the pharmaceutical industry, we are currently looking for an ambitious Junior Qualified Person. The company is a manufacturing organization and operates in more than 40 countries across the globe! A great environment to develop yourself in!

Role description

In this role you’ll be responsible for the release of batches of several CMO’s, 3 in Europe and 1 in Canada. It is a very dynamic role which requires effort and hard-work to grow into the Qualified Person role. It’s necessary to have 5+ years of experience within Pharma Quality Assurance & a MSc. In either (Industrial) Pharmacy or (Bio-)Chemistry.

Responsibilities

• Review of batch documentation of branded, and APIs and batch release in accordance with GMP and with the marketing authorizations
• Ensure quality oversight of manufacturing operations at the assigned CMOs and support from a QA technical perspective technology transfers, process validations, analytical testing and new product introductions etc.
• Review and approval of annual product review (APR/PQR)
• Ensures that the distribution of medicinal products complies with Good Distribution Practice (GDP)
• Preparation and execution of GMP/GDP training for employees

Requirements

• 5+ Years of experience as Quality Assurance Specialist within the Pharmaceutical Industry
• 5 + years of experience in GMP and GDP
• MSc. In either (Industrial) Pharmacy or (Bio-)Chemistry   
• Fluent in English
• Ambitious, dedicated & hard-working