Quality Assurance Officer II

Hyper Recruitment Solutions LTD; Oxford; On-site; GBP 42,000 - 62,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is recruiting a Quality Assurance Officer II for a leading biotech/pharmaceutical organisation in Oxford. The role focuses on development, implementation and maintenance of quality systems to ensure product integrity and regulatory compliance.

You will support batch reviews, manage investigations, drive CAPA and deviations, and contribute to audit preparations and execution within a GMP environment.

Qualifications

• 5+ years of quality experience in a pharmaceutical environment.
• Experience in aseptic manufacturing environments.

Responsibilities

• Provide guidance and coordination in the development and maintenance of Quality Assurance systems and activities.
• Manage batch review and final quality review activities supporting QP release and prioritisation.
• Drive improvement of GMP compliance, Change Controls, Deviations, and CAPA systems.
• Lead thorough root cause investigations and quality improvement activities.
• Review and approve SOPs, validation documents, GMP records and other quality documentation.

Skills

Assay experience

Job description

ROLE OVERVIEW

We are currently looking for a Quality Assurance Officer II to join a leading biotech/pharmaceutical organisation based in a collaborative and innovative environment. This is an exciting opportunity for a skilled QA professional to contribute to the development, implementation, and maintenance of essential quality systems that ensure compliance and product integrity.

In this role, you will play a pivotal part in supporting batch reviews, managing quality investigations, and driving continuous improvement initiatives. You will work closely with cross-functional teams, external vendors, and regulatory bodies to uphold the highest standards of GMP compliance and assist in audit preparations and execution.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Quality Assurance Officer II will be varied however the key duties and responsibilities are as follows:

• Provide guidance and coordination in the development, implementation, and maintenance of Quality Assurance systems and activities.
• Manage batch review and final quality review activities supporting QP release and prioritisation.
• Drive improvement of GMP compliance, Change Controls, Deviations, and CAPA systems.
• Lead thorough root cause investigations and quality improvement activities.
• As the QA Officer II, you will review and approve SOPs, validation documents, GMP records, and other quality documentation.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the QA Officer II we are looking to identify the following on your profile and past history:

• Experienceof Assays
• Proven extensive experience (5+ years) working within quality withina pharmaceuticalenvironment.
• Experienced working within Aseptic manufacturing environments

WHAT'S IN IT FOR YOU?

Joining our client offers the opportunity to work at the forefront of biotech and pharmaceutical manufacturing, supporting critical quality functions, and developing your expertise in a dynamic industry setting. You will be part of a collaborative team committed to excellence and continuous improvement, with access to ongoing training and development.

Key Words: Quality Assurance / GMP / Regulatory Compliance / Batch Review / Root Cause Investigation / CAPA / Audit / Risk Management / Vendor Oversight / Process Improvement

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.