Compliance Technician

Job Requisition ID:  32290
Department:  517 COGs - Engineering - General (517)
Category:  Production
Location: 

Wales

Date:  27 Jun 2024

 

Current Opportunity

 

 

SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines which address rare and life-threatening diseases.

Following strategic acquisitions and targeted developments, SERB has succeeded in establishing a consistent drugs portfolio focused on niche specialty pharmaceuticals to ensure continuous availability of life-saving medicines and answer unmet medical needs.

Our commitment is to continue to offer essential drugs meeting Public health needs.

 

Job Summary:

We are seeking a dedicated Compliance Engineer to join our Engineering Team. The ideal candidate will be responsible for ensuring the effectiveness of our Quality Management System (QMS) and supporting our Maximo and SCADA systems. The Compliance Engineer will play a key role in ensuring that our products meet the highest standards of quality and compliance. 

 

Key Responsibilities: 

 

Quality Management System (QMS) / Compliance: 

  • Maintain the QMS in compliance with regulatory standards.  
  • Support all aspects of Engineering Quality compliance activities (Deviations, Change Controls, CAPA, RCA). This also includes the daily logging of critical utilities status. 
  • Identify areas for improvement within the QMS and implement corrective and preventive actions. 
  • Ensure all quality assurance activities comply with GMP, FDA, and other regulatory requirements. 
  • Maintain detailed and organized documentation of all quality-related activities. 
  • Prepare reports on quality performance metrics and present findings to management. 
  • Carry out departmental periodic reviews and support document reviews, amendments, and creation. 

 

Maximo System Management: 

  • Support the Engineering coordinator in the Maximo Asset Management system maintenance. 

 

SCADA System Oversight: 

  • Support the operation and maintenance of SCADA system. 
  • Ensure SCADA systems are properly integrated with production processes and quality control measures. 
  • Monitor SCADA data to identify trends, deviations, and areas for improvement. 

 

Continuous Improvement: 

  • Lead initiatives in operational excellence to improve product quality and process efficiency 
  • Collaborate with cross-functional teams to implement best practices and innovations in quality management. 
  • Stay updated on industry trends and regulatory changes to ensure ongoing compliance and quality improvement. 

Serb Specialty 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.