Job Description

• Join a leading generics company driving change and continuous improvement

• Support the implementation of GMP/GDP documentation and enhance the QMS

• Utilise your expertise in quality systems and pharmaceutical manufacturing

• Contribute to the resolution and communication of non-conformances

Our client, a leading generics company, is seeking a skilled Quality Assurance Specialist to join their team in the South East. This is an excellent opportunity for an experienced professional to contribute to the company's commitment to quality and continuous improvement.

Position Overview

The Quality Assurance Specialist will play a crucial role in supporting the company's quality management efforts, ensuring compliance with GMP/GDP regulations, and driving enhancements to the Quality Management System (QMS). This position offers the chance to make a significant impact within a family-oriented and change-driven organisation.

Responsibilities

• Perform gap analyses against quality management systems

• Implement GMP/GDP documentation and enhance the QMS

• Review batch production records against marketing authorisation specifications

• Support reviews of key SOPs and amend systems

• Undertake and develop risk assessments as needed

• Review investigations and root cause analyses of discrepancies

• Generate SOPs and other quality documentation

• Provide training and coaching to team members

• Generate metrics and utilise Microsoft Excel proficiently

Requirements

• Experience in Quality Assurance roles in pharmaceutical companies

• Hands-on experience in quality systems on pharmaceutical manufacturing sites

• Technical knowledge of pharmaceutical Quality Assurance and GxP

• Knowledge of continuous improvement in quality systems

• Ability to perform gap analyses and make value-adding suggestions

• Experience with electronic quality management systems (e.g., Q-Pulse)

• Familiarity with reviewing batch production records

• Strong organisational and prioritisation skills

• Self-starter with the ability to interpret data and present outcomes

• Excellent communication skills and experience in training and coaching

• Proficiency in Microsoft Excel and ability to generate metrics