Data Analysis Officer - Morpeth, United Kingdom - Piramal Pharma Solutions

Piramal Pharma Solutions
Piramal Pharma Solutions
Verified Company
Morpeth, United Kingdom

4 days ago

Tom O´Connor

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Tom O´Connor

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Description

Job Overview


This role has responsibility for administering elements of the Pharmaceutical Quality System, including Quality Events, Corrective & Preventive Actions (CAPAs), Change Controls, Risk Assessments, and Data Trending & Analysis.


Essential Qualifications
The role-holder should be degree-calibre.


Relevant Experience


Knowledge of GMP and GDP, such as the MHRA's Orange and Green Guides, EU's Eudralex Volume 4, USA's CFRs 210 and 211, ISO, ICH, and PIC/S.

Undertaking self-inspection audits.

Administering elements of a Pharmaceutical Quality Management System.


Key Responsibilities

  • Lead of site roll out of GMP Training
  • Lead TrackWise Quality Event & Change Control (eQMS) and Ensur Editor (eDMS) System Training
  • Lead the weekly Change Control Committee
  • Support the Data Analysis Lead with Weekly/Monthly Metrics Preparation and Reporting
  • Support, as required, activities that relate to client audits and regulatory inspections.
  • Support, as required, the development of the Pharmaceutical Quality System.
  • Ensure there are no overdue Quality System records that are attributable to your name.
  • Keep abreast of and maintain systems in line with changing regulations and industry expectations.
  • Constructively challenge deficiencies and inefficiencies.
  • Identify and participate in continuous improvement initiatives within Quality.

Key Skills

  • Confidence presenting complex topics to both small and larger groups of people.
  • Confidence using electronic quality and document management systems.
  • Ability to organise group training sessions using Microsoft Outlook Calendar/Scheduling Assistant.
  • Ability to compile PowerPoint presentations to cover training topics related to the QMS
  • Ability to confidently interpret and present PowerPoint presentations prepared by others.
  • Ability to chair meetings and take scribe notes from those meetings.
  • Microsoft Excel Skills including: Tables, PivotTables, Graphs, VLOOKUP, Text to Columns & More.
  • Use of Microsoft Teams for preparation of shared documents.

Job Types:
Full-time, Permanent


Salary:
£30,000.00-£35,000.00 per year


Benefits:


  • Company pension
  • Cycle to work scheme
  • Flexitime
  • Life insurance
  • Onsite parking
  • Private medical insurance
  • Referral programme

Supplemental pay types:

  • Performance bonus

Ability to commute/relocate:

  • Morpeth: reliably commute or plan to relocate before starting work (preferred)

Work Location:
In person


Reference ID:
Piramal Pharma Solutions
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