Job Overview

This role has responsibility for administering elements of the Pharmaceutical Quality System, including but not limited to Product Quality Reviews, Technical/Quality Agreements, Self-Inspection, Customer Complaints, Second-level Batch Record reviews, and Document Control.

RELEVANT/ESSENTIAL EXPERIENCE:

‐An appreciation of GMP and GDP, such as the MHRA's Orange and Green Guides, EU's EudralexVolume 4, USA's CFRs 210 and 211, ISO, ICH, and PIC/S (desirable)

‐Administering elements of a Pharmaceutical Quality Management System (desirable)

‐High Level of Attention to detail

‐Excellent IT skills, proficient in Word / Excel

‐Organised and a good team player

Key Responsibilities
Administer and develop the following elements of the Pharmaceutical Quality System:

• Product Quality Reviews
• Technical/Quality Agreements
• Self-Inspection
• Customer Complaints
• Secondlevel Batch Record reviews
• Creation of Certificates of Conformity and Certificates of Analysis (including regulatory requests)
• Ordering of stationery and switchboard cover
• Preparation of documentation for EU release
• Validation / documentation store activities including pallet archiving / retrieving for all departments
• Update SOPs / FORMs, create new systems on a continuous improvement basis
• Collation of data for preparation of PQRs
• Document Control; the issuance and reconciliation of controlled documentation
• Ensure there are no overdue Quality System records that are attributable to your name.
• Support, as required, activities that relate to client audits and regulatory inspections.
• 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.

Job Types:
Full-time, Permanent

Benefits:

• Company pension
• Cycle to work scheme
• Employee discount
• Enhanced maternity leave
• Enhanced paternity leave
• Free parking
• Life insurance
• Private medical insurance
• Sick pay

Schedule:

• Flexitime

Ability to commute/relocate:

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

Work authorisation:

• United Kingdom (required)

Work Location:
In person

Reference ID:
QA Administrator March 2024

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