Senior Quality Specialist - Runcorn, United Kingdom - PE Global

PE Global
PE Global
Verified Company
Runcorn, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

The purpose of this role is to provide guidance and support to the Quality function ensuring designated Quality Systems are operated in compliance with Regulatory and Company standards.


Role:


  • To design, develop and manage Quality Systems and associated documentation to ensure compliance with Regulatory Standards and Corporate expectations.
This includes but is not limited to the following quality systems:

Vendor Assurance
b. Complaint Management
c. PQR's
d. Document Control
e. QMS Systems
  • TrackWise, Glorya, SAP Vendor Module etc.
f. Internal & External Audit program
g. QMS performance i.e., KPI's, SQC, Annual Reports etc.

  • To generate, issue and control CGMP documentation to support existing Quality Systems and processes.
  • To support continuous improvement of quality documentation and processes to ensure compliance with CGMP.
  • To design and deliver CGMP and Quality Systems training in line with Site requirements.
  • To carry out internal and external audits in line with plan. To act as lead auditor, to identify, action and close out all noncompliance issues with adherence to schedule.
  • To maintain and update information on latest Regulatory standards for use by company personnel.
  • CGMP Compliance
  • Vendors/Suppliers compliance and fitness for purpose


  • QMS Systems

  • TrackWise, Glorya, SAP Vendor Module etc.
  • Documentation Review Process
  • Annual Review
  • Planning, Organising and Controlling
  • Objectives and goals in line with performance plan
  • Day to day work load and prioritisation of activities
  • Day to day resolution directed by policy/procedures
  • Project planning and implementations for QMS updates and projects impacting both local department and across Site.
  • Planning and delivery of QMS training in line with Site support needs.
  • Contact with Others
  • Vendors/suppliers
  • Global Teva Contacts for Compliance
  • Decision Making Authority
  • Resolution of quality issues
  • Day to day need in line with policy and procedures
  • Changes to systems and processes
  • Application of CGMP

Requirements:


  • Relevant experience in Quality role within Pharma Industry (ideally approx.3 years experience in a similar role)
  • Graduate preferred.
  • Document control experience
  • Full understanding of cGMP.
  • Knowledge of Quality Systems / documentation.
  • Knowledge of QMS Processes such as Change Control, Deviation, CAPA etc.
  • Audit best practices.
  • Knowledge of Pharmaceutical GMP regulations (EU & USA)
  • Good numeracy and literacy skills
  • Computer literate
  • Report Writing skills
  • Audit Skills
  • Good Communication skills
  • Creative Problem Solving skills
  • Ability to prioritise effectively and work to tight deadlines
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