QA Specialist - Bedford, United Kingdom - Central Pharma

Central Pharma

Verified Company

Bedford, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

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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 selfinspection 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 daytoday activities.
Strong organisational and time management skills for the control of selfworkload.
Good team player.
Strong in project completion and CAPA closeout.
Flexible in supporting business needs.
Uses initiatives to drive improvements.