Job Title- Quality Assurance Specialist
Location- Goa
Main responsibilities:
Management of Quality Systems
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Compilation, Review & Management of overall Product Quality Reviews system.
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Act as site coordinator for change controls & management of change control system.
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Management of Deviation system.
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Management of Market complaint investigation system.
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Act as QA focal point for OOS/OOT management.
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Management of Training system.
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Oversight on Pest Control system.
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To perform Nitrosamine Assessment & review.
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Management of ICHQ3D requirements.
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Site coordinator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs)
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Act as focal point for Subcontractors/ Service Providers management.
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Management of overall Validation systems (Process, cleaning, transport & computerized system)
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Management of CAPA System.
Quality Management Systems
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Coordinating for conducting self-inspection as per planner and associated self-inspection activities.
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Review and Approval of GxP documents, batch manufacturing record and batch packing record in electronic-document system.
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Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc.
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Coordination of cGMP training activity including training of the people & review of training module.
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Initiation, implementation, and closure of change controls.
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Initiation of deviation and support in deviation investigation.
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Support in Market Complaint investigation.
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Implementation of assigned CAPAs and support in closure.
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Implementation of assigned Efficiency Reviews (ERs).
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Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned.
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Batch release & response to queries from QP.
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Management of Data integrity aspects.
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Participation and support in SMS initiatives.
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Support for HSE activities.
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Handling of Site Master File (SMF).
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Calibration document review of Engineering/QC/PMTD.
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User access management & review
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Analytical method creation
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Audit trail review
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Document archival/retrieval management.
Validation & Qualifications
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Quality focal point for all validations [Process, cleaning, transport & computerized system] and qualification activities.
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Quality focal point for temperature/ relative humidity mapping activities.
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Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length.
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Quality focal point for utilities & purified water system.
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Management of Site Qualification & Validation Master Plan
In-Process Quality Assurance [IPQA]
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Review & Approval of Master Batch Records & executed Batch Records
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Review and Approval of logbooks.
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Line clearance in Production.
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To perform In-process checks in Production.
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Sampling of products during routine production and validation.
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Quality oversight on shopfloor.
HSE
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Adherence to all health safety & environmental aspects as required by company policies and procedures.
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Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
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Conducting daily training in the +QDCI meeting address any unsafe condition.
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Take suggestion from associates to improve the work conditions with great safety and zero risk.
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Periodic review of the implemented procedures and evaluation of the same.
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Train people on safety and their job to ensure zero LTI and IWLT at workplace.
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Languages: English, Hindi, Konkani, Marathi
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Qualification: B.Pharm / M.Pharm
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Experience: 2-5 Years
