Senior Quality Systems Specialist

Our client, a well-known pharmaceutical company are looking for a Senior Quality Systems Specialist to join their team in the Quality (Systems) Department. The chosen candidate will be reporting directly to the Quality Systems & Compliance Manager.

 

Candidates with a lower level of experience are also encouraged to apply.

 

Key Responsibilities:

• Supporting and enhancing the department’s quality systems by focusing primarily on maintaining electronic quality management tools, ensuring regulatory compliance and contributing to process improvements.
• Supporting the development, control and continuous improvement of quality principles in alignment with the company’s internal quality requirements and GMP guidelines (such as cGMP, ICH, 21 CFR).
• Managing and maintaining the company’s documentation system to ensure effective control of quality documents such as SOPs, forms, the Site Master File, analytical methods, and batch records.
• Handling and managing the company’s electronic systems, ensuring full compliance with Computer System Validation (CSV) requirements.
• Participating in risk assessments related to ongoing site operations, as required.
• Leading and participating in the Site Internal Audit Program.
• Coordinating and managing client and regulatory audits conducted at the site.
• Overseeing the management of the site’s archiving system.

 

Ideal Candidate Profile:

• A post-secondary qualification in life sciences or a related field. A degree in life sciences is preferred.
• Previous experience in a pharmaceutical quality systems environment is considered an asset.
• Proficiency in Microsoft Office applications and familiarity with electronic management systems such as TrackWise and LabWare.
• Excellent interpersonal and communication skills both verbal and written.
• Strong attention to detail with a proven ability to analyze and troubleshoot problems, identify solutions, and implement effective methods and procedures.
• Highly organized with the ability to handle multiple projects and duties simultaneously.

 

Benefits:

• Flexible working arrangements including hybrid working.
• Performance bonuses.
• Health insurance.
• Career development opportunities.