QA Specialist Position
This is a fantastic opportunity to join our growing Quality Assurance team and play a key role in maintaining high product quality standards in a regulated GMP environment.
About the Role
We are seeking an experienced QA Specialist to support validation and qualification activities on-site, manage core QMS processes, and review and approve batch records, SOPs, and validation protocols/reports.
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.
Required Skills and Qualifications:
* 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).
Benefits:
This role offers a competitive compensation package and opportunities for career growth and development. The position can be offered on either a full-time or part-time basis, choose the hours that suit you.