At QbD Group , we offer knowledge and tailored (software) solutions in development, clinical, regulatory & compliance, production, and distribution for companies active in Pharma, ATMP , and Medical Devices / IVD . We are always looking for the next QbD’er in Qualification & Validation.
Both employees and FREELANCERS are welcome to apply for this opportunity.
What do we expect from you as a C&Q Lead?
As a Commissioning & Qualification (C&Q) Lead , you will take the lead in two major initiatives at a Small Molecule site :
- A site-wide C&Q Remediation Project following current assessments and gap analysis
- A capacity expansion project involving a new Spray and Post Dryer unit
Your responsibilities will include :
Leading qualification & commissioning efforts in both remediation and expansion projectsDefining C&Q strateg y and plans aligned with GMP and Risk-Based C&Q principlesEnsuring timely execution of documentation, FATs, commissioning, and qualification activities (IQ / OQ / PQ)Collaborating with internal and client stakeholders to ensure project alignmentSupporting audits and regulatory inspections as C&Q subject matter expertCoaching validation professionals involved in the project lifecycleWho are we looking for?
BSc / MSc degree in Life Sciences, Engineering, or related fieldMinimum 10 years of experience in Commissioning & Qualification within life sciencesSolid knowledge of Small Molecule manufacturing and Risk-Based C&Q methodologyFamiliarity with GMP, FDA, EMA regulationsFluent in English ; Dutch is a plusProven leadership and stakeholder management skillsAnalytical, solution-oriented, and able to manage complex project dynamics