Quality Officer - Ashby-De-La-Zouch, United Kingdom - LF&E Refrigerated Transport
Description
Job Title - Quality Officer
Job Purpose
Your role is to ensure quality systems are in place to ensure the business is compliant and meets any MHRA & GDP requirements.
Main duties will include:
- Biennial review and of Standard Operating Procedures and associated documents as needed.
- Instigation or Review of Deviation Report Forms and Corrective and Preventative Actions
- Sign Off
- Analysis and Review of Temperature Mapping of vehicles
- Sign Off
- Instigate Warehouse Temperature Mapping Exercises Analyse & Review Sign Off
- Preparation of End to End Temperature Traces on request from customers
- Management Of Change controls working with Quality Assessment Manager to instigate Risk Assessment of any change proposed.
- Prepare Validation Paperwork for RP Final Review and sign OFF
Responsibilities
- to ensure that the provisions of the licence are observed
- to ensure that the operations do not compromise the quality of medicines
- to ensure that an adequate quality system is established and maintained
- to ensure that adequate records are maintained
- to ensure that all personnel are trained
- to ensure full and prompt cooperation with product licence holders in the event of recalls.
- to ensure all equipment is tested and compliant to meet GDP requirements
In order to carry out your duties, you should have good knowledge of the conditions necessary for safe storage and distribution.
Essential knowledge of Good Distribution Practices (Guidelines of 5th Nov 2013 on Good Distribution Practice of medicinal products for human use 2013/C 343/01) & MHRA Guidelines, along with some experience in the logistics sector including vehicle safety is necessary.
Skills and Qualifications
- Have experience managing a QMS is essential
- Excellent customer service & communication skills and the ability to deal with people at all levels.
- Good methodical approach, attention to detail
- Ability to work under pressure in a fastpaced environment
- IT Skills
Job Types:
Full-time, Permanent
Salary:
£30,000.00-£35,000.00 per year
Benefits:
- Company pension
- Life insurance
- Onsite parking
Schedule:
- Day shift
- Monday to Friday
Experience:
- Quality assurance: 3 years (required)
Work Location:
One location
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