03 Nov
|
Baidyanath
|
Kolkata
03 Nov
Baidyanath
Kolkata
Job Description
• Overall responsibility for Quality Compliance across all the factories of Shree Baidyanath Ayurved Bhavan & Goodcare Pharma Private Limited.
• Create and implement best practice quality vision, strategy, policies, processes and procedures to aid and improve business performance, encouraging 3P for manufacturing and their requirements.
• Implement current quality processes and systems where appropriate to compliance with the current Good Manufacturing Processes and as per 3P requirements.
• Report on Quality activities on a regular basis to the Senior Management team, ensuring accurate and timely reporting of the relevant Key Performance Indicators and doing a proper Risk Assessments of the sites to analyze the gaps and mitigate the same.
• Provide leadership to various Quality Department Heads to ensure the product quality and site compliance and get the site ready for all types of 3P and Regulatory Audits.
• Developing the Quality Management System for all sites by updating their procedures and train the quality managers to compliance with the current regulatory norms.
• Support various project management to cross functional activity required for project execution and proper documentation.
• Ensure CQA SOP & Policy as per site specific requirements to implement and followed.
• Ensuring the Quality Specification for Existing Products and New Products to various sites for Raw Material, Packing Material, Semi Finished Goods & Finished Goods.
• Ensuring all SAP Bill of Material to be as per approved endorsement as per regulatory bodies.
• Coordination with all 3P for the compliance of the products manufactured for the brand.
• Ensuring the quality compliance and documentation from the 3P for the products manufactured under SBAB & Goodcare Brand.
• Coordination with various Cross Functional Departments for quality and product compliance.
• Handling Customers Complaints for various sites by providing support to the sites to compliance and provide adequate CAPA & finding proper RCA to minimize the same.
• Monitoring SAP data for QM, PP & SD module to control over any major inventory and compliance data compromise.
• Lead Plant team for COPP, FSSAI, Cosmetic & ISM certification audits.
• Provide training related to 21CFR PART 111, GDP, cGMP, Legal Metrology etc. to all members to upgrade with the current regulatory norms.
• Monitoring Complaints managements using 5 Why Analysis, Fishbone Diagram, FMEA.
• Costing for NPD products related to analysis and scale up to sites and various other technology transfer documents. Monitoring effectiveness of CAPA’s and various change controls, deviations and timely closure.
📌 Central Quality Head (Kolkata)
🏢 Baidyanath
📍 Kolkata