Senior Quality Systems Specialist

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.

Education and Experience

• Post-secondary qualification in life sciences or a related field a degree in life sciences is preferred.

Benefits

• Health Insurance
• Annual Performance Bonus
• Room for growth