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QA Specialist

4 months ago

Bedford, United Kingdom Central Pharma Full time

**QA Specialist Job Description**

**Role Responsibilities**
- To ensure all Central Pharma obligations are being met in terms of Technical Agreements, Manufacturer’s and Importer’s licence and Wholesale Dealer’s Licence.
- Ensure the PQMS is maintained in a state of control across all Central Pharma sites.
- Ensure activities performed by the Quality department are performed in accordance with GMP, GDP, ISO 9001 and ISO 13485 requirements.
- To control and preparation of PQMS documents including SOPs, validations, complaints, change controls, CAPAs, and deviations.
- To support regulatory audits including MHRA, and Home Office inspections.
- To conduct training of staff as and when required.
- To create, execute, and review of validation protocols, reports, and spreadsheets.
- To create and maintain validation master plans for all sites.
- To coordinate activities between production, customer services, warehouse and QA departments to ensure KPIs, deadlines and expectations are met.
- To investigate deviations, complaints, determine root causes and implement effective CAPA actions.
- To communicate with customers and suppliers as and when required.
- To review batch documentation, CoAs, Analytical and micro results.
- To review temperature data prior to product release.
- To participate self-inspection program.
- To be part of supplier assessment team and conduct external supplier audits.
- To represent Central Pharma at customer audits and meetings.
- Proactively contribute to creating a good team atmosphere.
- Any other such duties that from time to time may be required.

The above is not a complete and exhaustive list and other duties may be required to be undertaken as and when necessary.

**Experience, Skills, and Competencies**:

- Batchelor’s degree in science or related discipline.
- Minimum 3 years’ experience working within a pharmaceutical GMP/ GDP environment.
- Excellent communication skills.
- Ability to deliver effective presentations.
- Competent on Word, Excel, and PowerPoint.
- Professional handling of all internal and external communications with regards to quality.
- Good knowledge of pharmaceutical regulatory updates.
- Good attention to detail in day-to-day activities.
- Strong organisational and time management skills for the control of self-workload.
- Good team player.
- Strong in project completion and CAPA closeout.
- Flexible in supporting business needs.
- Uses initiatives to drive improvements.

**Job Types**: Full-time, Permanent

**Salary**: £30,000.00-£35,000.00 per year

**Benefits**:

- Bereavement leave
- Company pension
- Free parking
- On-site parking
- Sick pay

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Bedford: reliably commute or plan to relocate before starting work (required)

Work Location: In person

Application deadline: 10/09/2023