Interim Qualified Person (QP), fractional

The assignment

A pharmaceutical client in the south of the Netherlands needs QP capacity on a fractional basis: a named, experienced Qualified Person who is present on the days that matter, not a signature from a distance. You take on batch certification and release, and give the site's quality system the QP oversight it needs, working alongside the existing quality team.

What that looks like in practice: certifying and releasing batches in line with EU GMP Annex 16; reviewing the deviations, CAPAs and change controls that affect release; supporting self-inspections, supplier audits and regulatory inspections; and acting as a sounding board for the quality team on GMP decisions. The exact split of responsibilities is agreed with the client at intake and shared in the first conversation.

What we look for

• Meets the qualification requirements of Article 49 of Directive 2001/83/EC and is eligible to be named as QP on a Dutch manufacturing licence.
• A track record of batch certification as a QP in a GMP environment.
• Comfortable carrying QP responsibility on a part-time basis, with clear judgement on when an issue needs you on site.
• Independent, structured and able to work with a quality team without taking it over.

Practical

Freelance or interim engagement, part-time, on site in the south of the Netherlands. The number of days per week, the start date and the length of the assignment are agreed with the client at intake and shared in the first conversation. Rate depends on experience and scope and is agreed before any introduction. Contracted between your company and Axeleon with the Wet DBA requirements built in. Apply with a CV or LinkedIn link and a line about your availability; Russell reads every application himself and gets in touch if your profile fits.