Specialist, Customer CARE
3 weeks ago
Leadership role within the Quality Department responsible for the management and co-ordination of the site cGMP validation activities.
Support validation activity during design, installation & commissioning of new equipment, processes, packaging lines & facilities and utilities.
Ensure the validated status of site facilities, i.e., equipment, processes, CSV and utilities is complete and compliant with internal local and corporate procedures, relevant regulatory requirements and industry guidance.
Support Production departments in validation activities for processes and equipment.
Supporting external audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors.
Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed.
Ensure product quality through robust testing and process monitoring including the use of statistical techniques.
Successful candidates should have a degree in a relevant science or engineering discipline along with validation and qualification experience in a cGMP regulated life science industry, i.e., Pharmaceutical, API or Bio-tech. Brightwork is a recruitment agency for those seeking permanent work and a recruitment business for those seeking temporary work.
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