Qualified Person (Steriles)

Excellent Career Opportunity to Join a Highly Successful, International Organisation which Provides a Range of Products and Services to the Healthcare, Life Science and Associated Sectors

ROLE

• Execute Qualified Person (QP) Responsibilities, Duties, Batch Certification and Disposition as Defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16
• Ensure Products are Manufactured in Accordance with GMP, Site Procedures and Applicable Regulatory Requirements
• Maintain a Thorough and Up-to-Date Understanding of International Regulatory Guidance
• Maintain and Extend Technical and Professional Competence, Ensuring a Thorough Understanding of Any New Product or Process, Prior to Any QP Batch Certification and Disposition
• Undertake Regular Audits, Self-Inspections and Spot Checks
• Undertake and Support Investigations, Root Cause Analysis and Review and Approve Major/Critical Deviation, Complaints and Any Change Proposals with Process/Product Impact
• Undertake and Support the QMR Process
• Undertake and Support Implementation of Operation Excellence
• Act as Change Agent by Gaining Support for, and Driving Sustainable Improvements
• Ensure Continuous Improvement of the QMS
• Drive and React to System Trending eg Deviations, Complaints and Environmental Management, Ensuring Ongoing Quality Performance and Improvements.
• Establish and Maintain Effective Communication with Clients
• Backup for Other QP’s On-Site and Deputise for the Site Quality Director

REQUIRED (Essential)

• Minimum Degree in Chemistry, Pharmacy or Microbiology
• Minimum 3 years’ Experience Acting and Executing ‘Qualified Person’ Responsibilities and Duties as Defined in 2001/83/EC and 2001/82/EC
• Substantial Experience Working in a Pharmaceutical Quality Function within a Sterile Manufacturing Site
• Up-to-Date Knowledge of the Principles and Guidelines for GMP as per the UK “Orange Guide”, EU “Eudralex Volume 4”, US “CFRs” and Other Relevant Regulations
• Excellent Scientific and Technical Knowledge

REQUIRED (Preferable)

• Experience with Cephalosporins/Penicillin

REMUNERATION

• £90K Subject to Qualifications and Experience

RESPOND

• Call Luke Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail Luke@ARxConsultancy.com with Your Application, Including Your Current CV