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Commissioning and Qualification Manager
QbD GroupLimburg, Flemish Region, Belgium27 dagen geleden
FunctieomschrijvingLeading qualification & commissioning efforts in both remediation and expansion projects Defining C&Q strateg y and plans aligned with GMP and Risk-Based C&Q principles Ensuring timely execution of documentation, FATs, commissioning, and qualification activities (IQ / OQ / PQ) Collaborating with internal and client stakeholders to ensure project alignment Supporting audits and regulatory inspections as C&Q subject matter expert Coaching validation professionals involved in the project lifecycle BSc / MSc degree in Life Sciences, Engineering, or related field Minimum 10 years of experience in Commissioning & Qualification within life sciences Solid knowledge of Small Molecule manufacturing and Risk-Based C&Q methodology Familiarity with GMP, FDA, EMA regulations Fluent in English ; Dutch is a plus Proven leadership and stakeholder management skills Analytical, solution-oriented, and able to manage complex project dynamics
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 :
Who are we looking for?
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Manager Manager • Limburg, Flemish Region, Belgium