Quality Officer

**Salary**: Competitive salary

**Hours of Work**: Monday - Friday: 9.00am-5.00pm (Hybrid Working available after successful probation period.)

**Contract Type**:Full Time, 18 Months FTC (Maternity Cover)

**The Quality Officer Role**

You will report to the Principal Quality Officer, and you will be a diligent and organised individual.Do you have a working knowledge of tablets, capsules as a minimum, creams and steriles and associated processes, which would be advantageous?Could youalso demonstrate that you have a Working knowledge of a QMS - Deviations, CAPAs and Change Controls, Documentation Control? Do you have experience or knowledge of Pharmacovigilance, Medical Information?

**Quality Officer Duties**:

- **Quality Assurance**- to maintain compliance with Aspire Pharma’s EU and UK GMP/GDP/ISO 13485/ISO 14971 quality management system including training, non-conformance/deviations, launch activities, self-inspections; licence variations; productquality reviews, master batch documentation, Quality Technical Agreements, internal and external audits.
- **Quality Control**-launch activities prior to new product launch, review and control of documentation relating to batch release of products where Aspire Pharma is responsible for batch release. Updating and maintaining accurate Quality Managementdocumentation records, including temperature logs and trackers for several processes. Controlled Drug import licences.
- **Liaison with Relevant Stakeholders** - to liaise with internal and external stakeholders in timely manner to implement the changes to legislations, standards, deviations, CAPA and to launch new products.
- **Medical Information/Pharmacovigilance/Post-marketing Surveillance and Vigilance** - handling medical queries and feedback from customers (i.e., patients and healthcare professionals) and escalation within the team where required; maintenanceof and compliance with Aspire Pharma’s local Pharmacovigilance and Post-marketing Surveillance and Vigilance systems. Receipt and processing of pharmacovigilance-related reports, Medical Device incident reports, Vigilance related reports and events and ProductQuality Complaints. Control of standard responses, reconciliation with partners, Safety Data Exchange Agreements. Liaising with partners to ensure timely submission to Authorities.
- **Regulatory Intelligence** - maintaining awareness of existing and new legislation/guidance relating to UK and EU legislation on Medicines and Medical Devices and to ensure compliance with all regulatory requirements where applicable. Suchas EU Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP).

**Quality Officer Requirements**:

- Educated to degree or equivalent level within life science.
- Good IT skills including MS Word, Excel, Adobe and PowerPoint.
- Accuracy and attention to detail.
- Strong problem-solving skills and ability to work independently.
- Good communication skills, both written and verbal.
- Time management
- Experience in QPulse (desirable).

**Quality Officer Benefits**:
Complementing your salary, we also offer a variety of benefits and services to support your physical and mental well-being which include:

- Bonus scheme.
- Life Assurance cover of 4 x annual salary.
- Opportunities for professional development.
- Hybrid working available (up to 2 days at home) after an initial training period.
- Company events and celebrations throughout the year.
- 2 Corporate Social Responsibility (CSR) days per calendar year to volunteer in community projects.
- On-site parking.

**About the Company**: