Purpose
The Quality Control Specialist will ensure the quality of our products and processes, adhering to the Quality Management system. The role requires interacting with various stakeholders in the business and contributing to quality control and process validation activities.
Responsibilities
* Liaise with Quality Management (QM), Production, Engineering, and Administration personnel to validate processes.
* Perform quality controls and inspections with Production, Engineering, and Administration personnel.
* Contribute to maintaining, assimilating, and consolidating the company's quality management system documentation, including quality templates and work instructions.
* Aid in creating and implementing documentation and training for new processes within CSP.
* Investigate and troubleshoot issues.
* Report quality, health & safety, or environmental issues to QM or senior management personnel.
* Assist in the company's quality management system during priorities such as NCRs, internal & external audits, quality issues, or ongoing projects.
Daily Responsibilities:
* Validation and improvement of production processes and equipment.
* Validation and improvement of work instructions.
* Assist in organising and documenting CSP's training programmes.
* Work in cleanrooms and gown appropriately.
* Update and maintain quality documentation on the quality management system.
Monthly Responsibilities:
* Assist QM with validations, investigations, and improvement projects.
* Perform internal audits on production and engineering projects as part of the ISO9001:2015 management system.
* Assist in designing and implementing CAPA plans.
Requirements
* Minimum one year experience in a pharmaceutical/medical device/health and safety role.
* Level 7 degree or higher in a Science or Engineering discipline.
* Level 6/7 qualification in Quality, Process Validation or related discipline.
* Previous experience in the validation of manufacturing processes.
* Excellent skills in Microsoft Word and Excel.
* Excellent written and verbal communication skills.
* Excellent documentation skills (creation, formatting, archival, retrieval).
* Excellent planning and prioritizing skills; capacity to plan ahead to ensure tasks are completed on time.
* Experience in a GMP facility, in a documentation role is desirable.
* High attention to detail, and strong personal reliability.