Quality Assurance Officer

3 weeks ago

Wigston Magna, United Kingdom Nova Laboratories Limited Full time

Based in Martin House, the role will involve:

- Assisting the Principal Quality Officer with the administration of Q-Pulse.
- Validation of new modules on Q-Pulse and revalidation of existing modules where required.
- Updating and generating SOPs for the use of Q-Pulse.
- Undertaking or coordinating training sessions, including but not limited to: Initial and Periodic Q-Pulse, Pharmacovigilance and GMP training.
- Review of documentation including Standard Operating Procedures.
- Supporting departments in the review, update and issue of key documentation in order to sustain good documentation practice.
- Review of Q-Pulse records including complaints, change controls and deviations.
- Interrogation of Q-Pulse for monthly and quarterly KPIs.
- Client liaison for Quality matters, including assistance with customer audits
- A Science-based honours degree.
- Demonstrable experience with designing, implementing or validating electronic Quality Management systems or modules.
- A strong background in Quality Assurance with a minimum of three years’ work experience within the Pharmaceutical and/or Medical Device industries.
- Working knowledge of The Medicines Regulations 2012 as amended, ‘The Rules Governing Medicinal Products in the European union (Eudralex) - Volume 4’ and US Code of Federal Regulations, 21CFR.
- Experience of working with aseptic products and investigational medicinal products (IMP) and/or commercially marketed products would be an advantage
- Will have demonstrated the ability to drive effective change and continuous improvement during their career to date.

**Job Types**: Full-time, Fixed term contract
Contract length: 6 months

**Benefits**:

- On-site parking

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Wigston Magna, LE18 4YL: reliably commute or plan to relocate before starting work (preferred)

**Experience**:

- electronic Quality management system: 3 years (required)
- pharmaceutical work: 2 years (required)

Work Location: In person

Application deadline: 12/05/2023

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