Mitulkumar Shah Email & Phone Number

East Tamaki

Auckland, New Zealand

• In Process check in production area.• Pathogen management programme ( Environmental monitoring activities)• Change control for TGA & Non – TGA product.• Preparation of master formula & Specification both TGA & Non –TGA product. Preparation of Nutritional information & Nutritional values as per regulatory requirements.• Responsible for Document control ( Review and preparation of New and existing SOP’s)• Check and approve the art work of label as per regulatory requirements. Check & approve label for free sale certificate.• Liaison with customer regarding contract agreements, any Quality related query.• Document review and release of product.• Training to new employee as per company policies (Introduction, GMP training).• Internal audit and product Quality review as per company policies.• Preparation of Bulk Manufacturing document & Finish product packing document. Create BOM (BILL of material) for all Bulk and Finish Product.• Issue and maintain Code books, ( responsible for Issuing New codes for all Raw materials, packaging material , Bulk product, Finish product, Organic product, Animal restricted product)• Liaison with marketing team to make sure all orders comply with production Schedule & there should be no delayed

• Ensuring continuous improvement of the quality and compliance systems, Internal and external audits, customer complaints and special project work, Documentation like preparing Test report, SOP’s , Product release.Responsible for Sampling & testing of Raw materials, in process check, Finish products testing, cleaning lab glass wares.• Liaising with other department like Production, Purchasing, Engineering.• Products and QC testing. Completing daily Internal/ external quality reports.• Responsible for Order required chemical & other necessity for lab.• Working with Microbiology lab with minimum supervision when ever required.• Working with Research & Development department for new product development & new tests method.• Conducting regular maintenance and calibration of lab equipments• Environmental testing for production.• Maintaining a safe and healthy work environment.

Auckland, New Zealand

• Full Hands on Practical involvement and application in all respects of the manufacture task.• Involve in the continuous improvement of Quality Systems and maintain cGMP culture.• Good liaison with team, supervisor, QA, QC, Logistic, Micro lab and all other related departments.• To accept responsibilities in the area of Inventory control, Production schedules, documentation, final packaging, and data requirements for the products.• Practical aspects by separation technique, filtration process, freeze drying, and clean room flow.• Maintain and follow SOP’s.• Maintain excellent standard of Cleanliness, tidiness and maintenance

Auckland, New Zealand

Good understanding about GMP Mfg process like dispensing , granulation, compression and Coating.

Vadodara Area, India

• Primary responsibility to manufacture a variety of products with a desired quality.• Good understand of GMP guidelines, used in the manufacture of quality goods, helping me to undertake higher responsibilities.• In-process checking for viscosity, pH, Microscopy, colour match, layer separation, bioassay, and media preparation.• Knowledge about Fermentation process to produce Erythromycin, Penicillin and Cephalosporin antibiotics