Job Title: QA Specialist
Job Type: Full-time or Part-time hours
Industry: Biopharmaceuticals
About the Role:
Our client, a leading biotech company are seeking an experienced QA Specialist to join their growing Quality Assurance team. This is a fantastic opportunity to play a key role in maintaining high product quality standards in a regulated GMP environment while also supporting validation and qualification activities on-site.
Key Responsibilities:
- Serve as a technical QA advisor on GMP, validation, and compliance topics
- Manage core QMS processes including deviations, CAPAs, change controls, audits, and complaints
- Review and approve batch records, SOPs, and validation protocols/reports
- Support qualification activities for facilities, equipment, and utilities during start-up and routine operations
- Apply quality risk management principles to ensure compliance and project timelines
- Collaborate with cross-functional teams including QC, Manufacturing, and Engineering
- Drive continuous improvement initiatives across QA processes
Requirements:
- Bachelor’s degree (or higher) in a scientific or engineering discipline
- Minimum 5 years’ experience in QA within a GMP-regulated pharmaceutical or life sciences environment
- Hands-on experience with validation and a solid grasp of regulatory requirements
- Strong technical writing skills (SOPs, deviations, validation documentation)
- Excellent communication skills and ability to work independently and in cross-functional teams
- Fluent in English (written and spoken)
Please note that this role can be offered on either a full-time or part-time basis, choose the hours that suit you!
Onsite role
