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.
