Experience

Genetic Signatures

• Biotechnology Research
• 1 - 100 Employee

• Quality Control Manager

  • Oct 2018 - Present

  • Manage QC department’s daily activities – raw material, in-process, finished product testing.• Reviewing batch records, stability testing data and auditing laboratory notebooks and equipment calibration records.• Advising R&D and Validation teams in setting specifications & acceptance criteria for new products. • Review & approve technical documents using e-QMS Grand Avenue.• Liaising and answering to internal and external audits.• Manage all Out of Specification (OOS) investigations, deviations, CAPA and change controls as per cGMP using e-QMS. • Control inventory for QC targets and standards. • Extending technical support to prospective and existing customers.• In depth knowledge of real-time PCR machines and automated nucleic acids extractors compatible with the EasyScreen IVD Kits. • Manage and mentor the QC team. Show less

• Production Manager

  • May 2012 - Present

  • Responsible for manufacturing of all GSL products.• Write and review technical documents.• Assisting the R&D team in setting specifications and acceptance criteria for new products. • Implemented SAP-B1 (ERP for small businesses)• Control inventory and raw material handling.• Manage activities related to strategic purchasing in order to minimize operating expenses.• Maximize effectiveness of production team, equipment and materials within planned schedules while reducing costs.• In-house subject matter expert for eQMS and SAP-B1.• Responsible for receiving and processing orders using MYOB and SAP-B1and various courier services.• Manage and mentor the production team. Show less

• Product Development Scientist / Quality Management Representative

  • Apr 2010 - May 2012

  • Established an off-site manufacturing facility for GSL which includedo Sourcing and ordering equipment.o Setting up the laboratory.o Specifying designated areas for weighing, dispensing, labeling, assembly and packaging.o Developing methods and writing SOPs for the use of over-printers, liquid dispensers, solid dispenser, shrink-wrapper.• Responsible for manufacturing, release & stability testing of all kits. • Assessment of contract manufacturing companies.• Allocating and executing Improvement Requests.• Maintaining staff training registers and records. Show less



Intas Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Associate

  • Oct 2006 - Dec 2009

  • Manufacturing, maintaining and testing Bacterial Cell banks. • Testing for all products using PAGE, HPLC, UPLC and ELISA. • Compiling and reviewing Batch Release data, completing Data Recording Sheets and BWIs. • Preparation of COAs and Release documents for Commercial batches. • Preparation and review of SOPs, Method Qualification & Validation Protocols and Reports. • Ensuring compliance with ICH and EP guidelines. • Company representative during internal and external audits. Show less