Regulatory Affairs
Regulatory Affairs CTD / eCTD Dossier Preparation ANDA / NDA Product Registration Global Regulatory Submissions Injectable Products (if applicable) Lifecycle Management Regulatory Compliance Labeling Review Variation & R...
Engineering Manager
Lead the Engineering department of our sterile injectable manufacturing facility at GIDC Ankleshwar. Key responsibilities: - Plan and execute preventive maintenance, breakdown maintenance and calibration schedules acros...
Autoclave Operator
## Role Overview Operate and monitor autoclave cycles for sterilization. ## Key Responsibilities - Autoclave operation - monitoring - loading / unloading - cycle documentation. ## Qualification ITI / 12th Pass ## Expe...
Manufacturing Operator
## Role Overview Handle solution preparation, filtration, and autoclave loading / unloading. ## Key Responsibilities - Equipment sterilization - media fill support - cleaning - batch tagging - filter integrity test supp...
Vial Filling Operator
## Role Overview Operate vial filling and stoppering line. ## Key Responsibilities - Filling - stoppering - cleaning - in-process checks - sealing inspection. ## Qualification ITI / 12th Pass ## Experience 2-3 years...
Ampoule Filling Operator
## Role Overview Operate ampoule filling machine. ## Key Responsibilities - Filling operations - cleaning - volume checking - sealing inspection. ## Qualification ITI / 12th Pass ## Experience 2-3 years ## KPI Fillin...
Vial Washing Operator
## Role Overview Operate vial washing machines. ## Key Responsibilities - Machine operation - cleaning - in-process monitoring. ## Qualification ITI / 12th Pass ## Experience 2-3 years ## KPI Washing machine uptime ≥...
Ampoule Washing Operator
## Role Overview Operate ampoule washing machines. ## Key Responsibilities - Machine operation - cleaning - in-process monitoring. ## Qualification ITI / 12th Pass ## Experience 2-3 years ## KPI Washing machine uptim...
Recruitment Specialist
## Role Overview Manage recruitment for plant roles. ## Key Responsibilities - Screening - coordinating interviews - onboarding - vendor liaison - job postings - manpower MIS. ## Qualification MBA (HR) ## Experience 2...
Microbiologist
## Role Overview Conduct microbiological testing. ## Key Responsibilities - BET - MLT - environmental monitoring - water analysis - sterility testing. ## Qualification M.Sc (Microbiology) ## Experience 1-3 years ## K...
Executive / Officer — HPLC
## Role Overview Perform HPLC analysis. ## Key Responsibilities - RS - Assay - impurity profiling - calibration - instrument maintenance. ## Qualification M.Sc (Chemistry) ## Experience 2-4 years ## KPI Zero OOS from...
Executive / Officer — QC
## Role Overview Execute chemical and instrumental analysis. ## Key Responsibilities - Sampling - assay - related substances - documentation - stability testing. ## Qualification B.Sc / M.Sc / B.Pharm ## Experience 2-...
Senior Executive — Regulatory Affairs
## Role Overview Handle international dossier preparation. ## Key Responsibilities - CTD / ACTD submission - variation filing - regulatory queries - document review. ## Qualification B.Pharm / M.Pharm ## Experience 4-...
Executive / Officer — IPQA
## Role Overview In-process checks and line clearance. ## Key Responsibilities - Monitor production & packing - IPC - line clearance - online documentation. ## Qualification B.Pharm / M.Pharm ## Experience 2-4 years...
Executive / Officer — QMS
## Role Overview Ensure QMS implementation. ## Key Responsibilities - SOP management - deviation handling - CAPA - change control - internal audits. ## Qualification B.Pharm / M.Pharm ## Experience 2-4 years ## KPI C...
Executive / Officer — Validation
## Role Overview Execute validation protocols. ## Key Responsibilities - IQ/OQ/PQ execution for equipment - process & cleaning validation - calibration records. ## Qualification B.Pharm / M.Pharm ## Experience 2-4 yea...
Manufacturing and Autoclave Operator
## Role Overview Handle solution preparation, filtration, and autoclave loading / unloading. ## Key Responsibilities - Equipment sterilization - media fill support - cleaning - batch tagging - filter integrity test supp...
Vial Line Operator
## Role Overview Operate vial / ampoule filling lines. ## Key Responsibilities - Machine operation - cleaning - visual inspection - rejection recording. ## Qualification ITI / 12th Pass ## Experience 1-2 years ## KPI...
Senior Executive — Packing Department
## Role Overview Execute and supervise packing line activities. ## Key Responsibilities - Packing line operation - reconciliation - rejection monitoring - SOP adherence - coordination with QA. ## Qualification B.Pharm...
Officer — Production
## Role Overview Execute production activities as per BMR, ensuring compliance to SOPs and timelines. ## Key Responsibilities - BMR/BPR entry - line clearance - vial/ampoule loading-unloading - filtration operations - a...