Quality Assurance Officer
We are recruiting for a Quality Assurance Officer to work for a client in the Pharmaceutical industry. This role will focus on Deviation and CAPA management.
What you’ll do:
This role has QA involvement with a number of sites at our client, this will involve deviations and CAPA’s for all GMP impacting areas of our client. The in depth duties and responsibilities of this role are outlined below.
- Manages Incident and Deviation system by ensuring the WI/ SOP, systems and forms are compliant to statutory requirements, trained out to relevant personnel and executed consistently and effectively.
- Manages CAPA system on site to ensure CAPAs found are assessed before being raised and ensuring commitment from CAPA owners to completion dates, and ensuring execution of actions are managed to completion. Ensure appropriate risk management approach to the urgency with which CAPAs are initiated, effectiveness checked, closed or extended. Organises the Weekly CAPA Review Board.
- Maintains the Incident and Deviation database to ensure all incidents and Deviations are captured, Impact assessed and have time bound actions to address causes
- Ensures risks associated with Deviations and CAPAs are clearly communicated to all on site including Qualified Persons, ensuring there is no un-assessed risk with processes and products released for sale.
- Organises the right authority, expertise and groups of people and runs Deviation Investigations for determination of root causes and writes reports with appropriate risk assessment for safety, efficacy and quality as appropriate to incident and affected product.
- Performs incident and deviation investigations and opens and closes incidents, deviations and CAPAs. Applies expertise and a systematic approach to problem solving enabling the achievement of prompt and effective results with an identified proposal that deters problems from reoccurring.
- Ensures prompt approval, cancellation or closure of Incidents, Deviations and CAPAs
- Performs Self Inspections & supports Customer Audits. Ensures readiness for Regulatory Inspections.
- Support the implementation of a Quality and Compliance Excellence program for the site, particularly in management of Incidents, Deviations and CAPAs on site and ensuring the reporting of accurate data promptly (Daily, Weekly and Monthly as required). Drives down incidents and Deviation numbers by cultivating a culture of continuous improvement through CAPA implementation.
- Provide QA input to various other projects on site as required in the maintenance of company Quality Systems with respect to Change Management, Documentation Management System, C of A management and Support in other areas as deemed necessary by Quality Assurance Management.
We are seeking a candidate with a background in pharmaceutical quality assurance who has a strong understanding of GMP, deviations and CAPAs. You will be a highly detail orientated individual, with excellent written communication skills.
To apply, please email email@example.com or call 0161 300 9192 with any informal questions you may have.