QA Head

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Stallion Laboratories Pvt Ltd

time outline icon Ahmedabad, Gujarat, India

Posted on 14-12-2023

1 Vacancy

Description

To lead and and manage the strategic and o operational performance of Development Qu Quailty, contributing to the successful delivery of the business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to Regulatory and Quality compliance including Company standards, local and international regulations to achieve success in development projects and ensure the efficient and effective day-to-day running.
Responsible for to managing and facilitating the QMS implementation, standardization and adherence of site manufacturing in accordance to cGMP, ISO, CFR 820 applicable regulatory requirements as well as Quality Manual requirements including E Compliance and Laboratory Compliance y Compliance.
Develop, implernent and maintain the self-inspection and external (eg. supplier) audit program and conduct the self-inspection and supplier audits as per an established schedule ensuring all quality systems are reviewed and completed.
To manage and lead the projects within the FDA regulated industries on Documentation, Systems Set Up and Enhancements
Quality Control, Control, Quality Assurance, Regulatory-NDA/ANDA Preparations and Reviews, Auditing, Method and Process Validation Calibrations, Workflow Analysis and CMP training
Review audit readiness strategy and oversee audit preparedness for regulatory bodies inspections by managing field CAPAS
any regulatory actions, fullow ups and assisting in production problem resolution.
Improve process associated with the quality system to ensure review on a periodic basis continually increasing compliance as well as staying with current or ahead on industrytrends
Ensure Complaint Handling, Non-conformance and OOS investigations are carried out as per the procedures.
Manage Suppiler Quality Assurance and Supplier Quality Development to include supplier qualifications, action plans, audits,
performance monitoring, and assisting key suppliers towards industrialstandards of excellence.
Handle floor auditing, batch record review, AQL, inspections, and oversee Quality management functions in Manufacturing. Inspection, Packaging and Warehousing activities.
Responsible for approving SOP's, Batch Records Protocols and other CCMP documents and ensuring adherence to applicable
regulatory requirements.
Responsible for Continuous Process Verification using statistical tools. To actively participate in regulatory inspection readiness program and Act as spokesperson during regulatory inspections for assigned responsibilities.
Applied coaching techniques to support team members in improving performance. To assist all stakeholders on site in Implementing Quality Systems.complying with applicable regulations.