Quality Assurance Officer

Reacta Healthcare Limited; United Kingdom; On-site; GBP 30,000 - 42,000; Full time

Benefits offered by this job

Private Health Insurance

Life Assurance

Enhanced Annual Leave

Enhanced Pension Contributions

Job summary

Reacta Healthcare Limited is seeking a QA Officer to support the Senior QA Officer and Quality Administrator in delivering a professional QA service. You will help with ad hoc projects, ensure compliance with the Pharmaceutical Quality System, and assist with audits, CAPA, change controls, and recordkeeping.

The role emphasizes attention to detail, strong communication, and teamwork within a GMP environment. A Life sciences degree and IT proficiency are preferred.

Qualifications

• Knowledge of GMP and related guidance.
• Experience in a pharmaceutical manufacturing environment.
• Proven QA experience and documentation control.
• Proficient with Word and Excel, and general IT literacy.
• Strong written and verbal communication, and good organisational skills.

Responsibilities

• Review batch records and documents for GMP compliance.
• Support batch certification activities.
• Prepare quality data reports and trend analyses.
• Maintain quality logs and change controls.
• Coordinate with suppliers and internal departments for documentation.
• Assist internal audits and risk management activities.
• Support QA investigations and root-cause analysis.
• Perform general administrative tasks and ensure QS compliance.

Skills

GMP knowledge

Pharma manufacturing

QA experience

Microsoft Office

Communication

Organisation

Attention to detail

Education

Life sciences degree

Tools

Microsoft Office

Job description

Benefits Package: Private Health Insurance, Life Assurance, Enhanced Annual Leave, Enhanced Pension Contributions Great Place to Work 26-27 Sunday Times Best Places to Work 2024 BioNow Business Growth Award Winner 2024

The Opportunity

Due to continued growth, Reacta Healthcare are recruiting a QA Officer. The role of the QA Officer is to provide support to the Senior QA Officer and Quality Administrator to ensure the delivery of a comprehensive, efficient, and professional quality assurance service. The QA Officer will also support with ad hoc project work as required and ensuring the smooth running of the department.

Key Accountabilities

• Review executed Batch Manufacturing Records and associated documents to verify compliance with company procedures and GMP to support batch disposition.
• Support Batch certification activities
• Support the compilation of Quality data by providing summary reports and trends for Monthly quality data packs and the Management Quality Review data packs.
• Maintain up to date logs related to Quality activities including but not limited to Quality Events, CAPA, change controls, cleaning work orders and cleaning sheets, document change requests.
• Issue the numbered blank forms for Quality Events , CAPA, change controls, cleaning work orders and other blank records as required.
• Provide support for the management of records, issue, filing and archiving.
• Provide support for the supplier management process by liaising with suppliers to ensure that documentation is maintained up to date
• Complete or support internal audits, as required
• Participate in Risk Management activities.
• Participate in investigations and root cause analysis.
• Complete administrative tasks such as filing, photocopying, and shredding
• Work closely with other key departments within the business to promote compliance with the Pharmaceutical Quality System

Essential Skills, Qualifications and Experience

To be successful in this role, applicants need to have the following essential skills, qualifications and experience:

• Knowledge of Good Manufacturing Practice and associated guidance.
• Experience of working in pharmaceutical manufacturing environment.
• Previous QA experience
• Computer literate (Word, Excel).
• Strong communication skills, both verbal and written, to develop relationships internally and externally to the business.
• Good organisational skills
• Attention to detail

Desirable Skills, Qualifications and Experience

• Experience of MHRA inspections and or customer audits.
• Life sciences degree

Experience of working within a pharmaceutical or related GMP environment. Demonstrated written and oral communication skills. Demonstrated ability to work well as part of a team. Experience of IT software (e.g., Microsoft office, document managemen)

Reacta Healthcare are committed to creating a diverse and inclusive workplace where everyone feels valued and respected. We welcome applications from all individuals regardless of background and experiences. If you require any adjustments during the recruitment process, please let us know and we’ll do our best to support you