Stability Enrollment, Trending, and Documentation Scientist-4
Tasks
- Assemble analyze and report stability data
- Assemble review and trend stability data using statistical packages
- Author stability initiation documents
- Author stability sections of CTD dossiers
- Create and manage LIMS studies
- Create and track stability annual requirements
- Ensure training requirements are met
- Facilitate stability study initiation
- Follow stability procedures and ensure consistency
- Maintain stability performance expertise
- Manage batch identification
- Manage projects and escalate issues
- Own departmental deviations for stability operations
- Perform stability data entry reporting and trending
- Support change controls and CAPA
- Support health authority inspections
- Track stability batch enrollment
- Use risk based approach for compliance
Perks/Benefits
- N/A
Skills/Tech-stack
21CFR | CAPA | CGMP | Change Control | Common Technical Document | Data trending | ICH Q1A | ICH Q5C | JMP | LIMS | Management System | Microsoft Office | Quality Management System | Quality management | Risk-based | Risk-based approach | SAP | Statistical Analysis | TrackWise | Veeva
Education
Roles
Related jobs
-
AVP, Analytics - Belk (L10) INR 240K-360KCustomer Segmentation | Data Analysis | Data Mining | Likelihood estimation | Machine LearningCareer advancement | Employee wellness programs | Flexible work hours | Upskilling opportunities | Work from homeExecutive-level Full TimeHyderabad IN, India23h ago
-
Senior Data Scientist INR 2520K-3380KClassification | Clustering | Data Bricks | Descriptive Statistics | Feature extractionSenior-level Full TimeIndia - Hyderabad1d ago
-
Software Development Engineer 5 INR 2520K-3465KAWS | Aerospike | Algorithms | Apache Kafka | Apache SparkSenior-level Full TimeBangalore, India R1d ago
-
Associate Data Scientist INR 1400K-1600KAgentic AI | Agile | Clustering | Data Analysis | DatabricksMid-level Full TimeSHELL CENTRE – CHENNAI, India1d ago
-
Data Scientist INR 1500K-2700KAlteryx | Apache Spark | Cloud Computing | Data Transformation | Data WranglingMid-level Full TimeGurugram, DLF Downtown, India1d ago
-
Data Scientist INR 1800K-2500KData Preprocessing | Data Visualization | Data cleaning | Machine Learning | PythonOnsite interview requirementMid-level Full TimeIND-Pune-Smartworks, India1d ago
-
Data Scientist INR 1500K-2500KData Pipelines | Data Transformation | Data Visualization | Data Wrangling | Data cleaningEntry-level Full TimePune, Gera Commerzone SEZ, India1d ago
-
AI Data Scientist - Officer INR 900K-1200KARIMA | Agentic AI | Business Intelligence | Clustering | Data EngineeringEmployee volunteering support | Learning and development resourcesMid-level Full TimeAMRUTHAHALLI, NH 7,INTERNATION, India4d ago
-
Entry-level Full TimeGurugram, Haryana, India5d ago
-
Data Scientist INR 1500K-2000KAirflow | Big Data | Black-box | Black-box optimization | Data MiningMid-level Full TimeBangalore, Karnataka, India5d ago
-
Associate Process Manager INR 900K-1700KAWS | Azure | Data Pipelines | Data Validation | Drift DetectionMid-level Full TimePune, Maharashtra, India5d ago
-
Senior Specialist, Product Management - Data Analytics INR 2156K-2695KAPI | AWS | Agile | Azure | BI VisualizationSenior-level Full TimePune, India5d ago
-
Analytical Trending Scientist INR 1294K-2157KAnalytical testing | CGMP | Control charting | Data Visualization | JMPMid-level Full TimeHyderabad, India5d ago
-
Senior Data Scientist INR 2520K-3380KBitbucket | Data Analysis | Deep learning | Geospatial Data | GitEmployee Assistance Program (EAP) | Flexible working environment | LinkedIn Learning | Volunteer time offSenior-level Full TimeVadodara, GJ, India6d ago
-
Senior Data Scientist INR 2520K-3380KBias reduction | Data Aggregation | Data Modeling | Model Validation | PythonEmployee assistance program | Flexible working environment | LinkedIn Learning | Volunteer time offSenior-level Full TimeVadodara, GJ, India6d ago
-
Sr. Data Scientist INR 2520K-3380KBias reduction | Data Aggregation | Data Modeling | Data Quality | Data quality analysisEmployee assistance program | Flexible working environment | LinkedIn Learning | Volunteer time offSenior-level Full TimeVadodara, GJ, India6d ago
-
Data Scientist INR 945K-1250KApache Spark | Artificial Intelligence | Azure | Azure Machine Learning | ClusteringMid-level Full TimeBengaluru, India6d ago
-
21 CFR | CAPA | CGMP | CTD | Change ControlHybrid work option | Onsite collaborationMid-level Full TimeHyderabad, India6d ago
-
21 CFR | CAPA | CGMP | CTD | Change ControlMid-level Full TimeHyderabad, India6d ago
-
CAPA | CGMP | CTD | Change Control | Data trendingMid-level Full TimeHyderabad, India6d ago
-
AML Transaction Monitoring | Artificial Intelligence | Big Data | Data Preprocessing | Deep learningSenior-level Full TimeONE QUBE, India6d ago
-
Senior-level Full TimeGurugram, Haryana, India7d ago
-
Sr Data Scientist INR 2000K-2755KData Mining | Machine Learning | Power BI | Python | RFinancial security support | Healthcare coverage | Mental health resources | Paid time offSenior-level Full TimeIND - Karnataka - Bangalore - …7d ago
-
Senior Data Scientist INR 1750K-2040KApache Spark | Boosted Trees | Classification | Clustering | Data AnalysisHybrid work environment | Travel opportunitiesSenior-level Full TimeQ8 - Bangalore, India8d ago
-
Data Science Lead INR 1500K-2150KClinical Trial Data | Clinical trial | Data Integrity | Data Mining | Data QualityHealth and wellbeing benefits | Parental leaveSenior-level Full TimeHyderabad, India8d ago