Quality Assurance Officer

Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients.

• Quality Assurance
• Document Control
• Quality Management Systems (QMS)
• Internal auditing
• Analytical and troubleshooting skills

Quality Assurance Officer

Description
Location: Craigavon
Hours / Shifts / Pattern: 37.5 hrs per week
Business Unit: Almac Diagnostic Services
Open To: Internal & External Applicants
.:
HRJOB
11946
Who we are Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients.

The Opportunity

Almac Diagnostic Services supports clinical service, medical device and research activities within a highly regulated environment. Our Quality team plays an important role in ensuring that our work meets applicable quality standards, regulatory requirements and internal procedures. We are delighted to offer an opportunity for a Quality Assurance Officer to join our team in Craigavon. In this role, you will review documentation produced in support of our clinical, medical device and research activities, helping to make sure it is accurate, complete and compliant with relevant quality standards and Almac procedures.

On a day-to-day basis, you will work closely with colleagues across the business to review quality records, support internal audits and identify opportunities to improve our systems and ways of working. You will also help develop and update policies and procedures, support preparations for customer and regulatory audits, and provide training on quality systems and procedures.

Key responsibilities include:

• Review clinical service and medical device documentation before approval.
• Conduct internal quality audits and recommend improvements.
• Support corrective actions, change controls and continuous improvement activities.
• Ensure quality records are completed, reviewed and approved appropriately.
• Help develop policies, procedures and supporting quality documentation.
• Prepare quality assurance reports when required.
• Support preparations for customer and regulatory audits.
• Deliver training on quality procedures and systems, including new employee induction training.

Joining Almac means becoming part of a fast-paced, growing organisation within a highly regulated industry. We offer a supportive and collaborative working environment, with excellent opportunities for learning, development and long-term career progression across the Almac Group. Our approach is simple – we support, develop and reward our people, build fulfilling careers and together we advance human health. More information can be found here:
Life at Almac - Almac
What you need to be successful

To be successful in this role, you will bring a careful and analytical approach to your work, alongside the confidence to communicate quality requirements clearly and support colleagues across the business.

• A degree, or equivalent qualification, in Engineering, Biology, Physical Sciences, Mathematics or another relevant subject. Relevant experience undertaking similar duties may be considered in place of the academic requirement.
• Previous experience of quality assurance activities, including quality management systems, document control and training.
• Proficiency in Microsoft Word and Excel, or equivalent software.
• Good analytical and troubleshooting skills.
• Strong written and verbal communication skills.
• The ability to deliver effective training.
• A consistent ability to work accurately and maintain close attention to detail.
• A biological or…