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Process Expert Manufacturing.Ref: mc 23866

Salary:£600 - £700 per day

Added:06 Dec 2018

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical Research

An excellent opportunity has arisen to join a leading pharmaceutical company as a Process Expert Manufacturing. Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives. Shop floor support: * Provide front line support to manufacturing, working with the shift teams, , focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements. Validation - execution and review of protocol/report: * Support the execution of process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution. * Review and assure that validation protocols and report are technically correct. * Ensure protocols are executed as intended. Technical improvement execution: * Execute process improvements, scale-up. * Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables. Primary packaging closure assessment during changes: * Evaluate and assure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality. Assure consistency of Master Batch Records: * Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product. Deviation, Out Of Expectation, Out Of Specification, complaint handling: * Lead product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification. * Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures. Annual Product Reviews and Product Quality Reviews: * Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations. * Be a resource to other departments as Subject Matter Expert for the product and process knowledge. Training: * Provide training for assigned new processes and products. * Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position. Audit support: * Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit. Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment. Please contact Mark Cussens, Clinical Research Recruiter on Tel: +44 1727 817623 or email: Tel: +41 4350 86620 or email: Key People is a recruitment company with a reputation for providing good value that's been built up over 20 years. -We achieve results faster -Our candidates really are a cut above -We add greater value We think it's because we're a private company driven by clients, not by shareholders. For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career.

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