Quality Assurance Officer

4 weeks ago

Chesterfield, United Kingdom Peak Pharmacy Full time

**Quality Assurance Officer**

We are looking for a full time Quality Assurance Officer, working Monday to Friday, 8.30am to 5pm. This position will be hybrid working, with 2/3 days per week working in our Head Office in Chesterfield.

**ROLES AND RESPONSIBILITIES WILL INCLUDE**:
**Quality Management System**
- Writing and updating Standard Operation Procedures and Work Inspections (QMS and GDP) and performing effectiveness checks.
- Performing and reporting quality incident and deviation investigations including:

- Determination of the root cause (using the principles of root cause analysis).
- Ensuring appropriate remedial actions are taken in response to incidents/deviations.
- Performing impact assessments, ensuring all potential impacts are considered.
- Generation of CAPAs to address the root cause, casual factors(s), or contributing factor(s).
- Implementing continual improvements under the relevant procedure (CAPA or Change Control).
- Working alongside other departments to manage the implementation of changes.
- Adhering to ICH Q9 principles when generating risk assessments for planned changes etc.
- Giving training presentations and assessing staff competence, where deemed necessary.
- Helping to create a working environment where everyone is encouraged to raise potential improvements.
- Performing reviews on QMS documentation when assess as competent by the RP.
- Performing qualifications of suppliers, customers, and service providers.
- Participating in regular meetings with service providers to discuss the potential for continual improvements.
- Review of Technical Agreements with service providers, suppliers, and customers.
- Helping collate metrics on Key Performance Indicators to support routine trending and Quality Management Review meetings.

**Products**
- Investigating customer complaints (including those raised under the DMRC Yellow Card Scheme).
- Monitoring the sales patterns of high-risk products (e.g., pseudoephedrine and ephedrine).
- Helping to identify and investigate non-conforming orders (e.g., Product that has damaged secondary packaging or product that has experienced a temperature excursion during transit).
- Detecting signs of illegal activity where products may be falsified, counterfeit, stolen, or diverted (e.g., products that have suspicious secondary packaging or have been offered or requested in unusual circumstances).
- Managing product alerts that are reported by sources such as the MHRA and DMRC.
- Helping to manage recalls in a timely manner and perform mock recalls on an annual basis.

**Facility and Software**
- Performing routine temperature monitoring.
- Responding to temperature excursions alongside the RP.
- Performing seasonal temperature mapping studies (facility + vehicles).
- Qualifying equipment and performing challenge testing under different failure modes.

**Inspections/Audits**
- Performing audits on internal systems, processes, and departments according to the audit schedule signed off by the RP.
- Participating in audits on external service providers and suppliers.
- Auditing the wholesale areas at each branch on the Peak Pharmacy estate, and reporting findings to the RP and relevant Area Manager.

Background:

- P&AJ Cattee is authorised to procure, hold, and supply medicinal products under a Wholesale Distribution Authorisation. The company has held 3 licensed sites in Chesterfield and 2 licensed sites in Ilkeston.

In accordance with regulations 43 - 45AB of the Human Medicines Regulations 2021, all WDA(h) Holders must comply with Good Distribution Practice. The guidelines for GDP are based on Articles 84 and 85(3) of Directive 2001/83/EC, and cover 9 chapters which are relevant to Peak Pharmacy:
Guidelines of 5 November 2013 on GDP of medical products for human use (2001/83/EC)
- Quality Management
- Personnel
- Premises and Equipment
- Documentation
- Operations
- Complaints, Returns, Falsification, and Recalls.
- Outsourced Activities
- Self-Inspection
- Transportation

Licensed Wholesale Dealers must have at their disposal an RP, who is responsible for safeguarding the end user against potential hazards arising from poor distribution practices (i.e., the failure to comply with the chapters mentioned above). The role of the RP must be supported by the **QA Officer**, who will be involved in maintaining and improving the Quality Management System, and in helping to create a good quality culture at all levels throughout the business.

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