Global Quality Systems Senior Specialist
Role details
Job location
Tech stack
Job description
The successful candidate will play a pivotal role in developing, implementing, and supporting electronic Quality Systems across our Global Pharma Services operations.
This is an exciting opportunity for an experienced quality professional who is passionate about system excellence, regulatory compliance, and driving continuous improvement on a global scale.
As a Global Quality Systems Senior Specialist, you will be instrumental in driving the design, implementation, validation and ongoing support of Quality Systems throughout our global network. Working closely with international sites, internal IS teams and external partners, you will act as a subject matter expert (SME) in Quality System architecture, Computer Systems Validation (CSV), and regulatory compliance.
You will support key projects, lead documentation and lifecycle activities, contribute to audits, and ensure that systems meet both business needs and industry standards.
Requirements
Do you have experience in System architecture?, * Degree (or equivalent) in a Life Science or related discipline.
- Significant experience working within a regulated Quality System (GMP, ISO, etc.).
- Strong understanding of pharmaceutical quality system processes and regulatory requirements.
- Knowledge of regulations governing computerised systems and control.
Desirable Criteria
(The following criteria may be applied if a large pool of applicants exist)
- Experience writing detailed reports.
- Experience in manufacturing/packaging of solid oral dosage forms.
- Handson CSV experience (writing, reviewing, executing validation documentation).