• Serve as a subject matter expert on microbiology of probiotics and prebiotics.• Lead the quality control activities to ensure timely testing and release of samples.• Lead the design and execution of validation projects (Water, Environment, Facility monitoring, Disinfectant and Analytical method validation).• Review and audit test results.• Responsible for the smooth running of line control in production plant relating to testing/ checking of line and finished product.• To… Show more • Serve as a subject matter expert on microbiology of probiotics and prebiotics.• Lead the quality control activities to ensure timely testing and release of samples.• Lead the design and execution of validation projects (Water, Environment, Facility monitoring, Disinfectant and Analytical method validation).• Review and audit test results.• Responsible for the smooth running of line control in production plant relating to testing/ checking of line and finished product.• To participate in laboratory Instrument Calibration Plan, Good Laboratory Practices and safety schemes for the lab.• To participate in the Daily Quality Review meeting.• Any other duties as assigned from time to time• Oversee the laboratory for GMP, GLP and safety compliance.• Knowledge of standards and regulatory including those of Schedule M, WHO GMP, ISO, US FDA, ICH, FSSAI, FSSC.• Pharmacovigilance, internal and GMP audits handling (Internal, Customer and regulatory).• Development and maintenance of QMS documents • Risk and compliant management.• Quality metrics and Data management.• Develops and maintains collaborative working relationship with other managers. Show less

• Product development Oral solid Probiotic- Tablets/Capsules/Sachets and Liquid dosage forms, scale up, stability studies, Analytical method transfer and process validation.• Lead the design and execution of Analytical validation projects • Joint and witness analysis with the Different vendor like Cipla , Lupin and Torrent • Microbiology- a. Microbial techniques and handling of micro organisms (GPT, MLT, Sterility)..b. Invitro characterization of bacteria and yeast for… Show more • Product development Oral solid Probiotic- Tablets/Capsules/Sachets and Liquid dosage forms, scale up, stability studies, Analytical method transfer and process validation.• Lead the design and execution of Analytical validation projects • Joint and witness analysis with the Different vendor like Cipla , Lupin and Torrent • Microbiology- a. Microbial techniques and handling of micro organisms (GPT, MLT, Sterility)..b. Invitro characterization of bacteria and yeast for probiotic properties.c. Microbial environmental monitoring and controls.d. Microbial limit test for Raw materials and finished products.• Tablets/capsules/sachets Product stability studies as per ICH guidelines.• Trails- Formulation of new products • Validation studies- Water and UV validation, Facility monitoring.• Maintenance of documents pertaining to trail manufacture records, technical specification sheets, Record of Analysis, Preparation of SOP/Validation and deviation record. Show less

• In-process analysis involved in tablets/capsule/sachets formulation- Disintegration test, Dissolution test, Uniformity of weight test, Friability of uncoated tablets test, Tap Density, Bulk Density, Loss on Drying, Melting point, Hardness test.• Packing Material and Art works analysis of Carton , Shipper , Foil, Glass bottle , Pet Bottle ,and labels