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A market leading pharmaceutical business with a newly refurbished head office is currently undergoing a stage of expansion and as a result is seeking a Senior QA Officer to join the business on a permanent basis. As a Senior Quality Assurance Officer, you will play a pivotal role within the manufacturing facility and carry out the following duties:
*Ensuring GMP compliance.
*Ensuring GDP compliance
*Coordinate with commercial /Logistics for planning timely release of the batches.
*Coordinate with all departments to get the documents in time.
*Ensure batch documentation is obtained & reviewed on timely basis & provide necessary feedback to QPs for batch release.
*Ensure data logger information is available, Investigation of temperature excursion
*Updating warehouse & Logistic on the release status and keep log and release related documents up to date and in retrievable manner.
*Ensure that the batches going to pack are in compliance with licence i.e. artwork of carton, leaflet & foil, Expiry date, pack type & storage conditions.
*Maintaining QMS and comply to all the requirements like Change control, Deviation CAPAs, Training, Risk management documentation
*Responding to Quality related market complaints & documentation.
*Sampling, testing and Releases of Packaging Materials
*In-process, quality checks
*Internal audit compliance
*Responsible for supporting deviation close out, writing investigation reports and initiating/following up on corrective and preventative actions
*Leading Quality based projects working as part of a multidisciplinary team as required
*Responsible for supporting quality related customer complaint investigations and trending activities
*Supporting the development and implementation of improved quality reporting measures
*To promote continuous improvement of the Quality Management System
*Providing support and advice during cross functional investigations / projects and as required
*Able to provide direct support during customer and regulatory audits
*Approving pre and post execution validation documents
*Able to conduct self-inspections and external audits as appropriate
*Able to provide training in all aspects of Quality Management Systems and GMP including procedural updates
*The generation of Product Quality Reviews
*The generation of Technical Agreements and Summary of Finished Product Specifications as appropriate
*Supporting the review of all batch related documentation
*To support and maintain Business Continuity Management Plans and Environmental Health and Safety requirements as applicable to the QA Department
*Significant experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry (preferably manufacturing)
*Knowledge of EU quality related pharmaceutical regulations
*Experience of conducting quality based investigations and root cause analysis
*Experience of conducting self-inspections
*Understanding of solid dose manufacture
*Understanding of Product Quality Review requirements
*Understanding and experience of Change Control
*Good IT skills
*Decisive thinker able to work within agreed timescales
- CAPA- Root Cause Analysis- QMS - Change Control - Manufacturing
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