Quality Assurance Officer

ARx Recruitment Services; Rotherham; On-site; GBP 35,000 - 50,000; Full time

Benefits offered by this job

Discretional Bonus

Health Care

Job summary

ARx Recruitment Services is seeking an experienced QA Officer to join a growing pharmaceutical company in the UK. The role is full-time, on-site, based in the Rotherham area.

You will work with the Global QA team to ensure GMP compliance, support manufacturing licences and change controls, review SOPs, participate in inspections, and help deliver KPI targets while maintaining high quality standards.

Qualifications

• Experience within a pharmaceutical environment.
• A strong Quality Assurance background (2 to 3 years experience).
• Experience within sterile manufacturing environments (desirable).
• Good working knowledge of GMP requirements and quality systems.
• Strong communicator and team player.
• Confident using Microsoft Office products.

Responsibilities

• Working with the Corporate Senior QA Manager & QA departments in the UK to ensure the Global Document / Quality Management System (QMS) is being administered compliantly to GMP, Company Procedures and Regulatory rules & guidelines
• Contributing to the Global QA function in the UK and acting as a QA representative to support outsourced activities while working effectively with colleagues across multiple sites within the organisation
• Supporting activities relating to Manufacturing Authorisations/ Product Licences and Marketing Authorisations
• Reviewing and updating policies, Standard Operating Procedures (SOPs), forms, logbooks and templates
• Raising and overseeing the implementation of Change Controls and CAPA's when required
• Participating in site inspections by Regulatory Authorities
• Preparing information and taking part in the Global Quality Management Meetings (QMM) and tracking performance against KPI's and specified standards
• Writing, reviewing and contributing to Risk Assessments

Skills

Quality Assurance

GMP

Microsoft Office

Team player

Communication skills

Job description

We have all known someone who has been affected by Cancer, whether that be a friend, family member, or colleague. That is why, at ARx we are pleased to be working closely with a fantastic, highly regulated pharmaceutical company that plays a significant role supporting efforts to diagnose and treat advanced cancers more efficiently, and with less negative effect on the patient. As a growing organisation, they are seeking an experienced QA Officer to join their established Quality Team.

The Role: Full Time (Monday to Friday) On-site

• Working with the Corporate Senior QA Manager & QA departments in the UK to ensure the Global Document / Quality Management System (QMS) is being administered compliantly to Good Manufacturing Processes (GMP), Company Procedures and Regulatory rules & guidelines
• Contributing to the Global QA function in the UK and acting as a QA representative to support outsourced activities while working effectively with colleagues across multiple sites within the organisation
• Supporting activities relating to Manufacturing Authorisations/ Product Licences and Marketing Authorisations
• Reviewing and updating policies, Standard Operating Procedures (SOPs), forms, logbooks and templates
• Raising and overseeing the implementation of Change Controls and CAPA's when required
• Participating in site inspections by Regulatory Authorities
• Preparing information and taking part in the Global Quality Management Meetings (QMM) and tracking performance against KPI's and specified standards
• Writing, reviewing and contributing to Risk Assessments

Benefits:

• Discretional Bonus
• Health Care & More

About You:

• Experience within a pharmaceutical environment
• A strong Quality Assurance background (2 to 3 years experience)
• Experience within sterile manufacturing environments (desirable)
• Good working knowledge of GMP requirements and quality systems
• Strong communicator and team player
• Confident using Microsoft Office products