Quality Specialist, Contamination Control

Category: Pharma Location: Position:Quality Specialist, Contamination Control Duration:Part-time Location:Remote (based in Ireland) PositionOverview: Pharmalliance Consulting is a Dublin-based cGMP compliance and contamination control consultancy. We are looking for a graduate-level Quality Specialist to join us part-time (10-20 hours per week, fully remote, immediate start). You’ll work alongside our senior consultants to build client contamination control projects on CCbD, our Annex 1-aligned platform. That means mapping cleanroom areas, processes and personnel, material and equipment flows. You’ll also support risk and gap assessments, collate environmental monitoring data into clear Excel trackers, and draft and check reports, SOPs and training materials. We’re looking for someone with a degree in a science or engineering discipline, such as microbiology, biotechnology, chemical engineering, pharmaceutical science or chemistry. You should understand contamination control basics like cleanroom classification, gowning, cleaning and disinfection, and Environmental Monitoring. Strong attention to detail and good Microsoft Office skills are essential. GMP, lab or cleanroom experience from a placement or internship, and some knowledge of EU GMP Annex 1 or ICH Q9, would be a bonus. Above all, we want someone accurate and curious who’s keen to learn how and why contamination controls work. KeyResponsibilities: - Help set up and build client contamination control projects on the CCbD platform - Gather, organise and enter site and process information, such as cleanroom areas and grades, and personnel, material and equipment flows - Map manufacturing and support processes step by step to identify contamination risks and existing controls - Support contamination control risk assessments and gap assessments against EU GMP Annex 1 (2022) - Collate client data, including environmental monitoring data, into clear Excel trackers and summaries - Draft, format and check project deliverables such as reports, SOPs and assessment records - Track project actions and open items, and keep project records up to date - Support client presentations and cGMP training materials linked to CCbD projects Requirements Essential - Degree in a science or engineering discipline (for example microbiology, biotechnology, pharmaceutical science, chemistry or chemical engineering) - Understanding of contamination control principles: cleanroom classification, gowning, cleaning and disinfection, and environmental monitoring - Good process knowledge, with the ability to understand how a manufacturing or cleanroom process works step by step - Strong attention to detail in documents, data and records - Good Microsoft skills: Word, Excel, PowerPoint and Outlook - Clear written and spoken English - Ability to work to deadlines and manage your own time in a part-time schedule Desirable - Knowledge of EU GMP Annex 1 (2022) and contamination control strategy requirements - Placement, internship or project experience in a GMP, laboratory or cleanroom environment - Familiarity with quality risk management tools such as FMEA (ICH Q9) - Comfort working in web-based software platforms Benefits WorkingHours & Compensation - Hours:10–20 hours per week, part-time - Location:Fully remote - Start date:Immediate - Pay:Salary or hourly rate to be confirmed - Contract type and term:To be confirmed Details Originally posted on Himalayas