Data Analysis Officer Part Time

Morpeth, Northumberland
Piramal Pharma Solutions
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
On-site 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