Sally Meredith Email and Phone Number

Evaluate the gap analysis for new product development, technical transfers, and perform risk assessments.Facilitate technical transfers of softgels, working directly with customers to discuss processes and analyze issues.Oversee the technical aspect as subject-matter expert, working with other departments, including manufacturing operations, medicine, post-production, quality control, procurement, and scheduling. Study feasibility batches, evaluating established… Show more Evaluate the gap analysis for new product development, technical transfers, and perform risk assessments.Facilitate technical transfers of softgels, working directly with customers to discuss processes and analyze issues.Oversee the technical aspect as subject-matter expert, working with other departments, including manufacturing operations, medicine, post-production, quality control, procurement, and scheduling. Study feasibility batches, evaluating established parameters.Conduct manufacturing investigations, utilizing root cause analysis tools such as fishbone diagrams, 5 Why’s, and brainstorming; write CAPAs and change controls.Write the technical services protocols and reports, master batch production records, and procedures.Review and approve process validation and continued process verification documents.Conduct recipe design and development for products in FactoryTalk Pharma Suite; developed a user-acceptance confirmation and qualification testing.Evaluate statistical analysis and process capability via Minitab®.Participate in practical process improvement (PPI) 8-step method to identify opportunities to optimize processes and control costs. Show less

Adhere to consistent testing procedures (USP <61> and USP <62>).Ensured all microbiological quality parameters were maintained – from raw materials, finished products, stability samples, and purified water.Created Qualification and Summary Reports, as well as wrote protocol for various validation studies, including Disinfectant Efficacy Study and Environmental Monitoring Surface Testing.Evaluate microbial data; write quarterly and annual trend reports, as well as analyze… Show more Adhere to consistent testing procedures (USP <61> and USP <62>).Ensured all microbiological quality parameters were maintained – from raw materials, finished products, stability samples, and purified water.Created Qualification and Summary Reports, as well as wrote protocol for various validation studies, including Disinfectant Efficacy Study and Environmental Monitoring Surface Testing.Evaluate microbial data; write quarterly and annual trend reports, as well as analyze the statistical data.Review and make modification recommendations for microbiological procedures in order to maintain compliance with USP and cGMPs. Show less