Qualified Person (Steriles)
- Added on:
- 28 May 2021
- Contract type:
- Permanent
- Reference:
- 12561
- Location:
- Wiltshire
- Base Salary:
- £90K
Description
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