Overview

Quality Assurance Manager Jobs in European Economic Area at Planet Pharma

Title: Quality Assurance Manager

Company: Planet Pharma

Location: European Economic Area

Job Title: CMC Consultant

Location: Remote (Must be home-based in Europe)

Contract Type: Freelance (initially a 4–6-month project)

Salary / Rate: Competitive hourly rates on offer

Planet Pharma is partnered with a mid-sized European pharmaceutical company assisting them with the search for a CMC with at least 4 years of hands-on experience in both EU and US regulatory frameworks. The ideal candidate will have worked with Market Authorization Holders (MAH) and supported small molecule products, preferably in oral solid doses.

Key Responsibilities:

Author CMC sections (Module 3 & QOS) from scratch

Manage post-approval change management protocols (PACMPs)

Conduct regulatory assessments of change controls

Support tech transfers (end-to-end), including GMP documentation review

Perform compliance checks and ensure regulatory alignment

Requirements:

Proven experience with post approval changes management protocols (PACMP)

Strong knowledge of analytical methods, process validation, control strategies

Experience in US and EU submissions

Strong tech transfer experience (from one site to another)

Please apply with your CV and summary of relevant experience including specific PACMP, tech transfer, and CMC authorship projects.

Upload your CV/resume or any other relevant file. Max. file size: 800 MB.