Quality Assurance Officer

2 weeks ago

Elstree, United Kingdom BPL Full time

Headquartered in Elstree, Herts, BPL part of Kedrion, are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people.

Bio Products Laboratory manufactures pharmaceutical products derived from human blood plasma. These products are used to treat patients for conditions such as immunodeficiencies, coagulation disorders and critical care (blood volume deficiency).

We currently have an exciting opportunity for a QA Officer (24/7 shift) to join our Quality Assurance Team located in Elstree, Herts.

**This role is on a 24/7 shift (Monday to Sunday, 7am to 7pm and 7pm to 7am (4 days on, 4 off, 4 nights on, 4 off)**

**Please note our site is not easily accessible by public transport so please take this into consideration when applying.**

**The main purpose of your job role will be;**
- To assist all departments across site (primarily Production, Engineering and Technical) in prompt handling of quality incidents, deviations, customer complaints using Trackwise.
- To assist all departments across site (primarily Production, Engineering and Technical) maintain compliance to quality systems through auditing, training as required.
- To assist in prompt review of Batch Process Records.
- Primary QA contact throughout the shift and perform walk rounds throughout various departments ensuring quality is maintained across the facility.

**Key Duties and Responsibilities will be;**

To be primary QA contact across site throughout shift. Being able to discern what is potentially a major or critical deviation.

Receive, review and process quality reports on Trackwise (eg DR/QI/CAPA records) according to define procedures.

Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required.

Ensure that any documents presented for QA approval/checking are complete

Ensure a standard approach to quality systems throughout the facility, by undertaking both internal quality audits and QA inspections of facilities and activities, for departments across site.

Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including QA Management.

To co-ordinate and maintain the files for a range of quality records as required.

Review Batch Process Records, media fill records, autoclave records.

To participate as required in Regulatory and customer audits.

To undertake work related to job objectives as directed by QA management.

**In return we offer -**
- Competitive salary, and benefits
- Pension
- Life Insurance
- 25 days holiday
- On-site parking and a subsidised restaurant

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