Our Client, a well known Pharmaceutical company is looking for a Quality Systems Specialist to join their Quality Systems Department, reporting to the Quality Systems & Compliance Manager. This role focuses on maintaining electronic quality tools, ensuring regulatory compliance, and driving process improvements.
Your responsibilities will include:
- Support the development, control, and continuous improvement of quality principles in line with internal requirements and GMP standards (e.g., cGMP, ICH, 21 CFR).
- Manage and maintain the company’s documentation system, ensuring effective control of SOPs, forms, Site Master File, analytical methods, and batch records.
- Oversee electronic quality systems, ensuring full compliance with Computer System Validation (CSV) requirements.
- Participate in risk assessments related to ongoing site operations, as needed.
- Lead and contribute to the Site Internal Audit Program.
- Coordinate and manage client and regulatory audits at the site.
- Oversee the site’s archiving system, ensuring proper document retention and accessibility.
Working Hours: Monday - Friday: Flexi-Time
An attractive salary + performance bonus + room for growth
Requirements
- Must have strong analytical skills, attention to detail, and a collaborative approach.
- Detail-oriented with proven problem-solving skills and the ability to analyse issues and implement effective solutions.
- Hold an excellent level of written and verbal English
- Proficient in MS Office and familiar with electronic systems such as TrackWise and LabWare.
- Highly organised and capable of managing multiple tasks and projects simultaneously.
- Experience in a pharmaceutical quality systems environment is an advantage.
Benefits
- Health Insurance
- Annual Performance Bonus
- Room for growth
Education and experience
- Post-secondary qualification in life sciences or a related field a degree in life sciences is preferred.
