Job Information
Sanofi Group Assistant Manager Quality Assurance in Verna, India
Job title: Assistant Manager Quality Assurance
About the job
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
Responsible for oversight of quality systems
Responsible for audit compliance
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 Assessment & 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 GxP 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 cGMP 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]
Responsible for oversight of IPQA activities
Responsible for all time inspection readiness
Management of manpower on shopfloor in respective shift
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.
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 - -7 to 10 years experience