[Hiring] Quality Specialist, Contamination Control @Pharmalliance Consulting Ltd

Role Description

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.

• 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

Qualifications

• 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

Requirements

• 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

• 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