Principal Consultant at Talent Leads Consultants
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General Manager - Quality Assurance - Delivery & Design - FMCG (10-15 yrs)
General Manager - Quality Assurance - Delivery & Design - FMCG
Job Responsibilities :
GM Design and Delivery QA will assist CQA Head to manage overall QA /Regulatory compliance of development projects and support for the successful Technology transfers to sites including contract sites
- Work with Formulation development & technology transfer team and participate in product development & change control activities to ensure implementation of quality policies/mission/ and also assist the development team in ensuring our products comply with the relevant regulatory standards.
- Provide leadership within the organization in technology transfer and Design QA innovation and oversee planning, management, integration, and implementation of the QA policies and innovation missions.
- Provide QA oversight to Product Development and Technology transfer processing, laboratory analysis and timely closure of all project work requiring Quality Assurance approval and supports the transfer of projects to commercial production.
- Managing QA/regulatory compliance through Document Review & Approval such as method validations, development data, and stability data of Development & Scale up batches. Evaluates if there is any quality impact to process/product and take appropriate action.
- Lead and manage the team of professionals at Design QA & TT, including ensuring the development of the skills and expertise with changing internal and external needs
- Expected to have a fair understanding of P & ID, Engineering Drawing & Manufacturing Hardware involve in the processing of Creams, Lotions, Soaps.. Expected to roll out of these hardware to subsequent sites
- Conducting risk, Hardware gap analysis and legal compliance with local and country requirements
- Lead the roll of out the new products to subsequent sites including in-house and 3P sites.
- This includes planning and managing the implementation of product processes for registration, BOM extension, Specs/FC deployment, validation and commercial launch.
- Provide technical support for products at either the commercial or R&D stages.
- Recommends process improvement projects to internal and/or external partners and follow up on it implementation
- Develop, organize and conduct analysis to resolve and or correct manufacturing problems, process improvements, efficiency improvements, and produce reports to substantiate findings and establish validation acceptance criteria
- Responsible for successful technology transfers to contract manufacturing organizations
- Creates and maintains seamless interaction with other departments including the Manufacturing and Process Development Team, R&D, Compliance and Ops Quality, Regulatory, and with external partners
- Vendor audit/development for the new projects/products
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