of Quality Systems Compilation, Review & Management of overall Product Quality Reviews system. Act as site coordinator for change controls & management of change control system. Management of Deviation system. Management of Market complaint investigation system.
Act as QA focal point for OOS/OOT management. Management of Training system. Oversight on Pest Control system. To perform Nitrosamine backssment & review. Management of ICHQ3D requirements. Site coordinator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs) Act as focal point for Suppliers' management. Act as focal point for Subcontractors/ Service Providers management. Act as focal point
for Third Party audit handling. Management of overall Validation systems (Process, cleaning, transport & computerized system) Management of CAPA System. Quality Management Systems Coordinating for conducting self-inspection as per planner and associated self-inspection activities.
Review and Approval of Gx P documents, batch manufacturing record and batch packing record in electronic-document system. Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc. Coordination of c GMP training activity including training of the people & review of training module. Initiation, implementation, and closure of change controls. Initiation of deviation
and support in deviation investigation. Support in Market Complaint investigation.
Implementation of assigned CAPAs and support in closure. Implementation of assigned Efficiency Reviews (ERs). Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned. Batch release & response to queries from QP. Management of Data integrity aspects. Participation and support in SMS initiatives. Support for HSE activities. Handling of Site Master File (SMF). Calibration document review of Engineering/QC/PMTD. User access management & review Analytical method creation Audit trail review Document archival/retrieval management. Validation & Qualifications Quality focal point for all validations [Process, cleaning, transport & computerized system] and qualification activities.
Quality focal point for temperature/ relative humidity mapping activities. Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length. Quality focal point for utilities & purified water system. Management of Site Qualification & Validation Master Plan In-Process Quality Assurance [IPQA] Review & Approval of Master Batch Records & executed Batch Records Review and Approval of logbooks. Line clearance in Production.
To perform In-process checks in Production. Sampling of products during routine production and validation. Quality oversight on shopfloor. HSE Adherence to all health safety & environmental aspects as required by company policies and procedures. Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement. Conducting daily training in the +QDCI meeting address any unsafe condition. Take suggestion from associates to improve the work conditions with great safety and zero risk. Periodic review of the implemented procedures and evaluation of the same.
Train people on safety and their job to ensure zero LTI and IWLT at workplace. Languages : English, Hindi, Konkani, Marathi Qualification : B. Pharm/M. Pharm Experience -3-5 years experience Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, interaction, national origin, interactionual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at ! At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Job title : Executive QA Our Team: Implement Quality Assurance activities at Goa, Pharma adhering to global quality documents and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers' requirements, living Group's Values and Code of Ethics. Main responsibilities: Management of Quality Systems Compilation, Review & Management of overall Product Quality Reviews system. Act as site coordinator for change controls & management of change control system.
Management of Deviation system. Management of Market complaint investigation system. Act as QA focal point for OOS/OOT management. Management of Training system. Oversight on Pest Control system. To perform Nitrosamine backssment & review. Management of ICHQ3D requirements. Site coordinator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs) Act as focal point for Suppliers' management. Act as focal point for Subcontractors/ Service Providers management. Act as focal point for Third Party audit handling. Management of overall Validation systems (Process, cleaning, transport & computerized system) Management of CAPA System.
Quality Management Systems Coordinating for conducting self-inspection as per planner and associated self-inspection activities. Review and Approval of Gx P documents, batch manufacturing record and batch packing record in electronic-document system. Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc. Coordination of c GMP training activity including training of the people & review of training module. Initiation, implementation, and closure of change controls.
Initiation of deviation and support in deviation investigation. Support in Market Complaint investigation. Implementation of assigned CAPAs and support in closure. Implementation of assigned Efficiency Reviews (ERs). Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned. Batch release & response to queries from QP. Management of Data integrity aspects. Participation and support in SMS initiatives. Support for HSE activities. Handling of Site Master File (SMF). Calibration document review of Engineering/QC/PMTD. User access management & review Analytical method creation Audit trail review Document archival/retrieval management.
Validation & Qualifications Quality focal point for all validations [Process, cleaning, transport & computerized system] and qualification activities. Quality focal point for temperature/ relative humidity mapping activities. Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length. Quality focal point for utilities & purified water system. Management of Site Qualification & Validation Master Plan In-Process Quality Assurance [IPQA] Review & Approval of Master Batch Records & executed Batch Records Review and Approval of logbooks.
Line clearance in Production. To perform In-process checks in Production. Sampling of products during routine production and validation. Quality oversight on shopfloor. HSE Adherence to all health safety & environmental aspects as required by company policies and procedures. Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement. Conducting daily training in the +QDCI meeting address any unsafe condition. Take suggestion from associates to improve the work conditions with great safety and zero risk.
Periodic review of the implemented procedures and evaluation of the same. Train people on safety and their job to ensure zero LTI and IWLT at workplace. Languages : English, Hindi, Konkani, Marathi Qualification : B. Pharm/M. Pharm Experience -3-5 years experience Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, interaction, national origin, interactionual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at ! At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. PDN-99f26e84-bfd9-43ba-8ad2-b8269109f73f
