Quality Projects Associate

It is essential to us that each new colleague fits the corporate culture. We believe in an open and collaborative workplace where transparency is paramount. We encourage creativity, challenge accepted best practices and focus on internal knowledge. But most of all, we hold integrity and honesty in high regard. To us, mutual respect is the key to long-term growth. We focus on total client satisfaction in everything we do.

Dedicated exclusively to the life sciences sector, pi differentiates itself through services adapted to the specific needs of our partners and a thorough knowledge of industries such as (bio)pharmaceutical, biotechnology, medical devices and advanced therapy medicinal products (ATMPs).

The range of our expertise is as broad as the portfolio of clients we work for. Whether you are a biotech start-up, laboratory, an established pharmaceutical or medical device company, we can support you in delivering quality

To cater for our increasing growth, we are on the lookout for an Quality Projects Associate. More specifically, an organised and result oriented team player who dots the i's and crosses the t's.

Your responsibilities

• Quality Review of Validation Documentation, Change Records and Procedures
• Regulatory Impact assessments
• Coordination of Regulatory Submissions and Responses
• Support in Quality Management Systems (Validation, QRM, Change Management, Regulatory Systems…)

Your skillset

• Minimum Master's degree in science
• Minimum 1 year of experience within the pharmaceutical industry
• Interest in validation, quality and government agencies and documents
• Experience in validation and now wants to be on the other side (QA) or has already performed a similar job as QPA
• Scientific background and strong analytical skills
• Knowledge of medication legislation and organizations (FDA, EMA)
• Good writing and communication skills
• Dynamic, flexible, dealing with high work pressure
• Take initiative and be able to work independently
• Minimum of full professional proficiency in Dutch and English