Our client a Global Pharmaceutical Company, based in Liverpool is looking for a Process Expert to join their team.
Reporting to the Head of Secondary Formulation, the jobholder will provide technical input into Technical Transfer of formulation and filling operations. They will also provide front line expert support for production process-specific issues to Manufacturing for Secondary operations (formulation / filling / packaging) as well as drive continuous improvement in quality, yield and efficiency.
- Support knowledge and technical transfer of secondary process from site to site / NIV to CMO.
- Provide technical input into technical transfer plans and capital projects as appropriate.
- Provide front line support to Manufacturing, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Lead (as directed) product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.
- Use scientific and statistical knowledge to analyse data to provide process understanding, and to identify root causes of product and process failures.
- Support the execution of process validations, re-validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
- Review and assure that validation protocols and report are technically correct.
- Ensure protocols are executed as intended.
- Execute process improvements.
- Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables.
- 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.
- Be knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for contributing to process technology innovations.
- Support other departments as Subject Matter Expert for product and process knowledge.
- 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.
- Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audits.
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. Desirable MSc. or equivalent experience
- Fluent in English
- Significant demonstrable experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
- Experience of sterile filling, aseptic knowledge and problem solving, microbiological investigations, visual inspection of vials and syringes.
- Quality Assurance
- Quality Control
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