Quality Assurance Officer

Job Introduction

UK – Cramlington

We are looking for:

We have a new opening for a Quality Assurance Officer to join our team at our Cramlington site. You will play a key role in ensuring that the business meets the GMP standards expected of an API manufacturer. This role focuses on maintaining the Quality Management System and providing expert knowledge and overseeing product disposition.

This is a fantastic opportunity to work in a dynamic environment, with excellent benefits and career development opportunities.

Key roles and responsibilities:

• Provide expert guidance on GMP requirements, ensuring compliance across all relevant areas.
• Conduct meticulous batch documentation reviews and carry out batch disposition as delegated by the Head of Quality.
• Operate the Quality aspects of SAP to ensure batch disposition aligns with cGMP requirements.
• Support cGMP compliance during the design, cleaning, commissioning, validation, and API production processes.
• Oversee supplier qualification/requalification processes and execute audits as required.
• Conduct cGMP audits of the Cramlington facilities and ensure corrective actions are implemented.
• Ensure procedures within the Quality System remain valid and appropriate through planned reviews.
• Review and maintain compliance of process validation documentation and periodic quality reviews (PAR).
• Coordinate the QA aspects of the site’s stability programme in accordance with cGMP.
• Manage deviations, change controls, CAPAs, complaints, and internal audit processes.
• Provide quality review and sign-off for plant cleaning and facility validation documentation.
• Interact with Contract Manufacturing Partners to fulfil cGMP and Quality Agreement requirements.
• Contribute to project teams, ensuring QA aspects are completed according to plan.
• Stay informed of industry quality developments and share relevant insights with site teams.
• Provide training on Quality/GMP processes and support site trainers in quality standards.
• Assist in planning and executing regulatory inspections and customer audits, acting as a subject matter expert when required.
• Maintain personal training records and ensure compliance with departmental training requirements.
• Adhere to Health, Safety, and Environmental regulations, working in an organised and efficient manner.
  
  
  

Requirements:

Essential:

• Proven experience in successfully applying regulatory skills to resolve challenges in a GMP environment.
• Ability to effectively contribute to multi-disciplinary scientific teams.
• Strong organisational skills with the ability to prioritise tasks efficiently.
• Excellent attention to detail and a methodical approach to work.
• Strong written and oral communication skills.
• Effective problem-solving abilities.
• Good IT skills, particularly proficiency in Microsoft Word and Excel.
  
  
  

Desirable:

• Degree or equivalent qualification in chemistry or a related field.
• At least two years' experience in Quality Assurance roles within an industrial setting.
• Leadership skills with the ability to mentor and develop team members.
  
  
  

Our Company:

“We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.

We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.

Our Cramlington site, just north of Newcastle, has an established history of cGMP

manufacturing services for an array of Active Pharmaceutical Ingredients (API), ranging from pilot scale to commercial metric ton scale. The Cramlington Site has more than 100 cubic meters reactor commercial capacity and has been inspected and approved by the MHRA, FDA and other regulatory authorities. The site operates from small scale in the laboratory through to large manufacturing scale. It also offers chemistry and analytical development service.

• We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
• We offer state of the art working environment on site.
• We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
  
  
  

Why Should You Apply?

• This is an opportunity for you as a Quality Assurance Officer tomake a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
• Build and shape your career in an environment that sets and commits to the highest standards.
• To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
  
  
  

Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 21,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.