Quality Officer

A growing Pharmaceutical company are looking to expand their Regulatory team with the addition of a Quality Officer. They are looking for an individual that is hard working and self-motivated to assist with all things quality.

Key Responsibilities

• Support the QA Manager with maintaining and improving the Quality Management System (QMS).
• Manage and progress Deviations, CAPAs, Change Controls and Complaints in a compliant and timely manner.
• Conduct batch review activities and support the batch release process, identifying and escalating any issues.
• Assist with internal audits, risk assessments, recalls and continuous improvement initiatives.
• Prepare and maintain documentation including SOPs, PQRs and KPI reports for management review.
• Support supplier/customer qualification and liaise with external partners to ensure QMS records are progressed to closure.
• Ensure compliance with GMP/GDP requirements and internal quality procedures.

Experience and Qualifications Required

• Minimum 3 years’ experience in a QA role within a pharmaceutical environment.
• Strong understanding of Quality Management Systems and GMP/GDP regulations.
• Experience managing Deviations, CAPAs, Complaints and Change Controls.
• Competent in document review, report writing and SOP creation.
• Skilled in root cause analysis and risk/impact assessments.
• Highly organised with strong attention to detail and the ability to prioritise effectively.

Personal Attributes

• Professional, proactive and solutions-focused.
• Passionate about quality, compliance and patient safety.
• Self-motivated, collaborative and confident in constructively challenging processes to drive improvement.

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