Quality Officer Pharmaceutical

2 months ago

Petersfield, United Kingdom Workshop Recruitment Full time

**Quality Officer (pharmaceutical)**

**Petersfield**

**Permanent**

To provide full administrative support for the Quality Control and Assurance and Medical Information / Pharmacovigilance activities of the company. It is essential you hold a life science degree and any work experience within pharma would be an advantage.

**Duties include**:

- Quality Control - launch activities prior to new product launch, control of documentation relating to release of medical devices and medicinal products onto the UK and Ireland markets, and import licences.
- Quality Assurance - maintenance of and compliance with EU GMP /GDP / ISO 13485/ ISO 14971 quality management system
- Internal and External Liaison - to facilitate timely implementation of changes to legislation or guidance, investigation of complaints/non-conformances and deviations
- Regulatory Intelligence -maintaining awareness of existing and new legislation/guidance relating to and ensuring compliance to EU GMP, GDP, GVP and GCP; Medical Information; Post marketing Surveillance and Vigilance; Medical Devices including all ISO activitiesrelevant to medical devices
- Medical Information /Pharmacovigilance /Post-marketing Surveillance and Vigilance - handling medical queries and feedback from customers (i.e., patients and healthcare professionals); maintenance of and compliance with local Pharmacovigilance and Post-marketingSurveillance and Vigilance systems; self-inspections; control and maintenance of product-related references; preparation and control of standard responses; and reconciling queries with partners; receipting pharmacovigilance-related reports, medical deviceincidents, vigilance-related reports and events

**Skills, Knowledge and Experience**
- Science Graduate
- 1-3 years’ experience
- Knowledge of GMP / GDP desirable
- Knowledge of an electronic quality management systems desirable
- Excellent communication skills
- High attention to detail
- Strong time management skills and be well-organised
- A good team player
- MS Office experience
- Previous work experience within a pharma quality, compliance, pharmacovigilance or medical information role would be an advantage

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