MAIN PURPOSE OF ROLE:
• Support the Electronic Quality Management System (EQMS).
• Manage issues (e.g. Complaints) and documents within the EQMS.
• Support site Good Manufacturing and Distribution Practice (GMDP) compliance.
• Prepare agenda and minutes for Quality systems meetings.

KEY RESPONSIBILITIES:
• Assist in the Pharmaceutical Quality Management of all Waymade, Sovereign Medical, MediFast International and contractors products.
• Maintain the principles of the GMDP throughout the company.
• Assist in the generation and maintenance of procedural and controlled documentation.
• Provide support for scheduling and maintaining the internal and external auditing programme.
• Responsible for reviewing and maintaining Quality system logs.
• Undertake quality surveillance activities to ensure that the manufacturing units, manufacture and pack of each (or batch of) product is in accordance with current GMP and Warehouse units control products within current GDP.
• Support and agree resolution on technical and quality issues relating to the production and testing (if applicable). Report issues which may impact on releasing these products to Qualified Person and Head of Quality.
• Collating batch paperwork for QP or RP review to support manufacturing, packing and QC documentation checking and reviews prior to the certification and release of the product.
• Generate summary and trending information for the Pharmaceutical Quality System for periodic review within the guidelines of the Quality system.
• Generate summary reports for Annual Product Quality Review.
• Complete reviews assigned in relation to the following Pharmaceutical Quality Systems:
• Change Control
• Deviations
• CAPA
• Complaints
• SOPs
• Product Quality reviews
• Audit (internal, external) schedule
• Risk Assessments
• Root Cause Analysis
• Assist in conjunction with the Quality, Technical and Regulatory departments for certification of products by:
• Obtaining the manufacturing packaging and QC documentation required
• Maintenance of release records and sample stores in compliance with GMP requirements
• Provide assistance in preparing for Regulatory, Home Office and external customer inspections and completion of quality questionnaires.
• Other duties as required.

PERFORMANCE STANDARDS:
• Demonstrate flexibility and willingness to assist.
• To be punctual, polite and courteous always.
• Ability to work on own initiative.
• Good communication skills.
• Ability to work in a team environment.

Qualifications:
A level Grade B/C in Biology and or Chemistry
IT literate in Microsoft Software Packages, particularly Word, Excel and Outlook
Pharmaceutical Sciences graduate
Knowledge of Pharmaceutical EQMS
Knowledge of Sage ERP (Waymade Stock Control Programme)

Experience & Competences
Previous experience working in a similar role within a Pharmaceutical environment
Strong attention to detail
Able to work flexibly and under own initiative
Full, valid UK driving licence

Knowledge & Skills
Excellent communication, both written and oral
Excellent working knowledge of Good Manufacturing Practice.
Time management Skills
Ability to work under pressure

Personal Qualities
Enthusiastic and highly motivated
Self starting and able to work on own initiative
Reliable and punctual

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