[ref. c07475517] Senior QA and Compliance Officer - Runcorn

Overview:

About the Company

As a global health care group with more than 100 years of experience in pharmaceuticals, medical devices, and life sciences, we have more than 30,000 employees worldwide, with just over 1000 in the UK & Ireland.

About the Role

Reporting to the QMS Manager, you will provide dedicated quality oversite and support across the site.

Responsibilities:

• Ensure robust and effective change management and deviation management systems are in place to meet regulatory requirements.
• Provide support to the site in completion of quality investigations, robust root cause analysis and relevant CAPA through training and mentoring.
• Ensure all QMS activities requiring QA review/input are completed to a high standard within required timeframes.
• Develop and report on quality KPI’s to identify trends and improvements needed.
• To identify, design and deliver GMP training to staff in order to support improved application of GMP/GDP standards.
• Implementation of appropriate risk management policies, procedures, systems, and processes, ensuring evaluation processes are effectively applied across the site.
• Identifying areas of continuous improvement in terms of Quality Culture, Compliance and Site quality systems.

Qualifications:

• Experienced QA Professional with extensive GMP/QMS Experience
• Science/pharmacy-based degree (or equivalent)
• Strong communication and influencing skills.
• Experience with Change Control, Deviation and Investigation management, Root cause analysis and CAPA
• Experience in the use of Trackwise
• Experience in Quality Risk Management
• Robust understanding of sterile production