Quality Specialist - #141843

Come and Save Lives with Us!

SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies.

For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes.

Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.

Having The Right Culture Is As Important To Us As Having The Right Portfolio. We Are Guided By Our Four Values

• We make patients our priority
• We act with accountability and integrity
• We work together as one team
• We look for better ways forward
  
  

By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.

Broad Overview

To provide GMP quality assurance (QA) oversight to the company’s external network. Providing technical GMP QA expertise and input to the quality management system (QMS) compliance of SERB Pharmaceuticals at Weybridge, Surrey.

The job holder will be responsible for driving GMP compliance, initiatives and remediation externally and internally under the leadership of the Quality Assurance Manager.

As The Quality Specialist Your Responsibilities Will Include

• Main quality contact with contract manufacturers and other GMP contractors. Forming effective working relationships with key personnel within the company’s external network and driving positive outcomes for the business.
• Generate comprehensive investigations and risk assessments for quality related issues (deviations and out-of-specification results) identified in licensed and unlicensed medicinal product manufacture, ensuring compliance with regulatory standards and meeting patient supply requirements.
• Review and approve critical GMP documentation, including batch manufacturing/packaging record (BMR/BPR) masters, standard operating procedures (SOPs), and validation protocols and reports.
• Operate as a GMP subject matter expert ensuring compliance of the company’s manufacturing contractors.
• Develop effective Corrective and Preventive Actions (CAPAs) plans for application externally and within the company. Monitor progress and close out of these CAPA within the QMS.
• Monitor quality metrics and trends, driving continuous improvement initiatives.
• Perform and lead GMP audits of contractors as assigned by the QMS and in support of the wider company as required.
• Review and coordinate Product Quality Reviews generation as required.
• Perform internal audits in accordance with company’s QMS requirements.
• Ensure that quality related tasks are prioritised appropriately.
• Collaborate with cross-functional teams to implement quality enhancements.
• Ensure effective and timely communication with all internal and external stakeholders for issues and projects.
• Support the Quality Manager with other tasks as requested.
• Ensuring all medical activities adhere to relevant industry regulations, ethical guidelines, and company policies
• Carry out other reasonable tasks as required by the Line Manager.
• Ensuring that all interactions and engagements are carried out in accordance with Company Values.
  
  

The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To Be Successful In This Role, You Should Demonstrate

• BSc in a life science subject or comparable pharmaceutical industry experience.
• 5+ years’ pharmaceutical industry experience, in GMP roles.
• Experience in performing external and internal GMP audits.
• Strong communication skills, attention to detail and the ability to work collaboratively within cross functional teams.
• Comprehensive knowledge of GMP regulations and quality standards relating to solid/liquid pharmaceutical formulations.
• Proven track record in applying GMP knowledge and remediation planning within manufacturing environments.
  
  

Company Benefits

• 25 annual leave days plus bank holidays and 3 annual company closure days (to be taken between Christmas and New year)
• Competitive Pension Scheme
• Private Medical Insurance
• Discretionary Bonus Plan
• Paid Maternity and Paternity Leave
• Academic Study Assistance
• Eyecare vouchers
• Employee Assistance Programme
  
  

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.