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EU: Qualified Person (QP) - Pharmalex, PT (237705) - Black Diamond Networks EU: Qualified Person (QP) – Pharmalex, PT (237705) Life Sciences & Technology Share Share on LinkedIn Share on X (Twitter) Share on Facebook Share on Email Title: Back up QP Location: Hybrid / will be a mix of remote with some onsite days required in Lisbon, PT Start Date: Immediate need Duration: 6 months plus Time Commitment: Preference is for a candidate with full-time availability but may be able to work if candidate can do 3 or more days per week commitment Description: The client is looking for a skilled, Portuguese speaking QP to perform batch certification of secondary packaging activities for commercial and experimental human use drugs. Ideally, the client would like a candidate with close to full-time availability but there may be flexibility. Responsibilities: • Ensuring compliance with GMP. • Verifying all documentation generated for and during each of the processes performed. • Issuing Certificates of Compliance for the manufacturing operations developed at this facility. • Ensuring that an 8-hour on-site self-inspection is carried out per year and monitoring all actions arising from them. • Providing annual training for staff relevant to manufacturing operations (4 hours including testing). • Attending in-person inspections for renewal of the Good Manufacturing Practices Certificate and developing and monitoring all actions arising from them (this inspection is every 3 years). • Attend routine inspections by competent authorities in person. EU: Qualified Person (QP) – Pharmalex, PT (237705) About Black Diamond Networks Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions. Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Start Date ASAP This position is no longer accepting applications.