Injection & OSD Water Plant Operator / Maintenance Technician

Agio Pharmaceuticals Limited; Pune District; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Agio Pharmaceuticals Limited in Pune, India, is hiring an experienced Assistant Manager – Injectable Production to lead sterile injectable manufacturing operations and ensure strict GMP compliance. You will supervise end-to-end processes from vial washing to packing, and coordinate with QA/QC, Engineering, and Warehouse to maintain schedule adherence.

The role requires strong oversight of documentation (BMR/BPR), CAPA, and audits, along with robust training and team management to drive

Qualifications

• M.Sc. in a relevant field (Life Sciences/Pharmacy) with hands-on experience in sterile injectable operations.
• Minimum of 11 years of total experience with strong exposure to GMP and regulatory audits.

Responsibilities

• Supervise end-to-end injectable manufacturing operations (washing, filling, sealing, inspection, packing) per SOPs and cGMP.
• Prepare and coordinate monthly production plans with QA/QC, Engineering, and Warehouse.
• Ensure compliance with regulatory requirements, aseptic processing guidelines, and sterile manufacturing procedures.
• Review and approve batch documents (BMR/BPR) and related quality system records.
• Lead internal and external audits, self-inspections, and CCS/QA activities.
• Manage QMS documents including deviations, CAPA, incidents, and market complaints.
• Oversee media fill studies, aseptic simulations, contamination control, and sterilization processes.
• Ensure accurate batch documentation, GDP, and ERP-based batch order creation.

Skills

Sterile Injectable Manufacturing

Aseptic Processing

Aseptic Filling

Vial/Ampoule Washing

Visual Inspection

cGMP/GDP Compliance

Media Fill / Process Simulation

QMS (Quality Management System)

Deviation/Change Control/CAPA

Market Complaint Investigation

OOS/Incidents

BMR/BPR

SOP Review/Preparation

Process Validation

Equipment Qualification

ERP System

Track & Trace

Production Planning

Team Management

Training

Education

M.Sc.

Tools

ERP System

Track & Trace

Job description

Job Description Assistant Manager – Injectable Production

Designation: Assistant Manager – Injectable Production
Department: Production – Injectables
Qualification: M.Sc.
Total Experience: 11.4 Years
Experience with Agio Pharmaceuticals Ltd.: 1.8 Years

Job Summary

Experienced pharmaceutical professional with 11.4 years of experience in sterile injectable manufacturing, production planning, aseptic processing, cGMP compliance, quality management systems, and regulatory audit readiness. Skilled in supervising end-to-end injectable manufacturing operations, ensuring product quality, maintaining regulatory compliance, and driving continuous improvement in sterile manufacturing facilities.

Key Responsibilities

• Supervise and control end-to-end injectable manufacturing operations, including vial/ampoule washing, manufacturing, filling, sealing, visual inspection, and packing, in accordance with approved SOPs and cGMP requirements.
• Prepare monthly production plans and ensure timely execution in coordination with QA, QC, Engineering, Warehouse, and other cross-functional departments.
• Ensure compliance with current regulatory requirements, GMP guidelines, aseptic processing practices, and sterile manufacturing procedures.
• Review and approve production-related documents, batch manufacturing records (BMR), batch packing records (BPR), SOPs, protocols, reports, and other quality system documentation, as authorized.
• Plan and execute internal audits, external regulatory audits, self-inspections, and sterile facility compliance activities.
• Handle Quality Management System (QMS) documentation, including deviations, incidents, change controls, market complaints, Out-of-Specification (OOS) investigations, and CAPA.
• Investigate market complaints related to manufactured products and ensure effective implementation and closure of corrective and preventive actions.
• Execute and monitor media fill studies, aseptic process simulations, Contamination Control Strategy (CCS), and contamination prevention activities.
• Ensure proper execution and documentation of sterilization processes, equipment qualification, process validation, calibration, and preventive maintenance activities.
• Conduct initial and ongoing training for production personnel on SOPs, batch documentation, GMP, GDP, aseptic techniques, and applicable protocols.
• Ensure accurate batch documentation, Good Documentation Practices (GDP), online in-process entries, and batch order creation in the ERP system.
• Operate and supervise track-and-trace systems to ensure product traceability and compliance with applicable requirements.
• Review batch production records and analytical documentation to ensure completeness, accuracy, and compliance before submission to the relevant quality function.
• Coordinate deviation investigations, root cause analysis, risk assessment, and implementation of CAPA to prevent recurrence.
• Ensure products are manufactured, handled, and stored according to approved procedures and established quality standards.
• Monitor equipment and facility conditions to maintain a controlled sterile manufacturing environment and ensure operational readiness.
• Support validation and qualification activities and ensure all associated records and reports are maintained.
• Perform additional responsibilities assigned by the Department Head to support production targets, product quality, and operational excellence.

Key Skills

• Sterile Injectable Manufacturing
• Aseptic Processing and Aseptic Filling
• Vial/Ampoule Washing, Filling and Sealing
• Visual Inspection and Packing
• cGMP, GMP and GDP Compliance
• Media Fill / Aseptic Process Simulation
• Contamination Control Strategy (CCS)
• Quality Management System (QMS)
• Deviation, Change Control and CAPA
• Market Complaint Investigation
• OOS and Incident Management
• Batch Manufacturing Record (BMR) and Batch Packing Record (BPR)
• SOP Preparation and Review
• Process Validation and Equipment Qualification
• Sterilization Process Monitoring
• Internal Audits and Regulatory Audits
• ERP System and Track & Trace
• Production Planning and Team Management
• Training and Cross-Functional Coordination

Professional Profile

A results-oriented injectable production professional with extensive experience in sterile pharmaceutical manufacturing, production supervision, regulatory compliance, documentation management, and quality assurance coordination. Capable of managing production activities, maintaining GMP-compliant operations, supporting audits and investigations, and ensuring consistent product quality and manufacturing efficiency.