Quality Manager OTC Finished Product Manufacturing SME

On Application
27 Nov 2018
27 Dec 2018
Quality, QA / QC
Contract Type

Job title: OTC finished product manufacturing SME with RA, Quality/GMP & regulatory experience. 

Reports to Technical Project Manager OTC GTO - EMEA 

Direct Reports None  

Scope of the Role: 

To perform a gap analysis review of production documentation against the following: 

  • Registered documentation, 
  • Current cGMP, 
  • Internal standards, 
  • Industry standards e.g. ICH. 

Standard processes and procedures have been developed to support this compliance review. The applicant will also initiate and oversee the remediation activities to close any gaps identified.

The gap analysis review will include but not be limited to; 

  • Review of the existing manufacturing site documentation will include e.g. 
  • Product and material specifications, 
  • Validation documentation, 
  • Stability documentation, 
  • Periodic Quality Reviews, complaint history and any CAPA produced as a result, 
  • Change control history, 
  • CAPAs, 
  • Manufacturing batch documentation 
  • Regulatory dossier 
  • Request additional documentation as required 
  • Carry out a Preliminary Risk Assessment The gap analysis will be completed using the relevant Client documentation to detail the cGMP Compliance and Product Health Assessment. 
  • Carry out a Risk Assessment on the findings to prioritise activity 
  • Based on the regulatory variation strategy develop a manufacturing/analytical plan for the remediation work to ensure compliance. 
  • Request a quote for the works to be completed at the relevant manufacturing site and/or contract research organization (CRO) and agree a timescale for the works to be completed. 
  • Review and approve protocols and reports from the manufacturing site and/or CRO that control the required remedial work, i.e. process or analytical revalidation 
  • If required, prepare an Expert Statement to support regulatory submission 
  • Support request for information requests which may arise on regulatory variation submission 
  • Update Client Specification systems as required. 
  • Prepare Expert Statement to support regulatory submission 
  • Support request for information requests which may arise on regulatory variation submission 
  • Update Client Specification systems such as GSS, CONNECT, etc. 

Key Internal Stakeholders; 

  • Supply Chain – Manufacturing 
  • Regulatory Affairs 
  • Quality Assurance 
  • Project Management 

Experience Required; 

  • Educational – A relevant degree or suitable pharmaceutical industry experience. 

Work Experience: 

  • A minimum of 8 years in a pharmaceutical manufacturing or product development environment 
  • Knowledge and understanding of different manufacturing processes used with the OTC environment is a distinct advantage. 
  • Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems 
  • Technical writing and documentation review abilities 
  • Project management, communication and prioritisation skills. 
  • Demonstrable experience of working with external manufacturers. 
  • Preferred understanding of EMEA regulatory processes and requirements.


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