Senior QA Officer

Hyper Recruitment Solutions LTD; Newcastle upon Tyne; On-site; GBP 35,000 - 55,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is seeking a Quality Assurance Specialist to support site compliance with GMP, EU GMP, and Specials guidelines within a pharmaceutical environment. The role involves QA/QAQC collaboration across manufacturing and regulatory activities to ensure high-quality radiopharmaceutical products and patient care.

Ideal candidates hold a degree in pharmacy or chemistry and have proven Quality Systems experience in GMP facilities; knowledge of radiopharmaceutical environments

Qualifications

• Degree or higher in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology.
• Proven experience within Quality Systems and GMP-regulated facilities.
• Knowledge of radiation and radiopharmaceutical environments advantageous, beneficial for role.

Responsibilities

• Maintain site compliance with GMP, Specials guidelines, applicable pharmacopoeial standards and EU GMP requirements.
• Review production and analytical methods, SOPs, batch records and QC documentation for accuracy and data integrity.
• Assist with deviations, incidents, investigations, OOS results, CAPAs, change controls and regulatory queries.
• Support validation activities, batch reviews, incoming material release and inspection readiness.
• Assist Quality Control activities including environmental monitoring and out-of-spec reporting/investigations.

Skills

Quality Systems

GMP knowledge

Regulatory knowledge

Communication skills

Education

Degree or higher in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology

Job description

QUALITY ASSURANCE SPECIALIST

An exciting opportunity for a Quality Assurance Specialist to join our client, a leadingspecialist pharmaceutical organisation. This role will support site compliance with Specials guidelines, current international pharmaceutical legislation, EU GMP requirements and internal quality standards.

The successful candidate will contribute to a culture of quality and operational excellence, working across Quality Assurance, Quality Control, manufacturing and regulatory activities. This is an excellent opportunity to support the delivery of high-quality radiopharmaceutical products that help improve patient care worldwide.

KEY DUTIES AND RESPONSIBILITIES

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

• Support the overall maintenance of site compliance with GMP, Specials guidelines, applicable pharmacopoeial standards, SmPC requirements and company procedures.
• Review production and analytical methods, SOPs, forms, batch records, QC testing, microbiological results and quality documentation to ensure accuracy, compliance and data integrity.
• Assist with the management of deviations, incidents, investigations, OOS results, CAPAs, change controls, complaints, recalls, risk assessments and related quality trending.
• Support validation activities, batch review, incoming material release, Quality Management Review preparation, inspection readiness, internal self-inspections and regulatory inspection responses.
• As the Quality Assurance Specialist you will support Quality Control activities, including environmental monitoring, microbiological sample interpretation, sterility testing, QC logbook review and the timely reporting and investigation of out-of-specification results.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Quality Assurance Specialist we are looking to identify the following on your profile and past history:

• A Degree or higher level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology.
• Proven experience within Quality Systems and the operation of GMP-regulated facilities, supported by an excellent and up-to-date working knowledge of current EU GMP requirements.
• Knowledge of radiation and radiopharmaceutical or pharmaceutical manufacturing environments would be advantageous.
• A strategic and technically minded approach, with sound general management knowledge, strong communication and interpersonal skills, and the ability to manage priorities effectively under pressure.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer.

We welcome applications from anyone who meets the role requirements.

WHAT'S IN IT FOR YOU?

• The opportunity to contribute to a culture of quality and excellence within a specialist nuclear medicine environment.
• Exposure to a broad range of Quality Assurance, Quality Control, validation, compliance and regulatory activities.
• The chance to work collaboratively with quality and operational teams while supporting inspection readiness and continuous improvement.
• A meaningful role helping to ensure the quality and compliance of products that contribute to improved patient care.

Key Words: Quality Assurance / Quality Control / GMP / EU GMP / Radiopharmaceuticals / Specials Guidelines / Quality Management Systems / Deviations / CAPA / Change Control / OOS / Validation / Environmental Monitoring / Data Integrity / Regulatory Inspections