Walk-in Drive For Technician / Staff - Injectable Manufacturing

Intas; Bavla; Vor Ort; INR 300.000 - 420.000; Vollzeit

Zusammenfassung

Intas Pharmaceuticals SEZ Plant in Gujarat seeks Diploma/ITI holders for hands-on sterile manufacturing operations, including washing, sterile filling, lyophilizers, autoclaves, CIP/SIP, line clearance and basic equipment logkeeping.

Degree holders will supervise lines, ensure BMR/SOP adherence, participate in QMS, audits readiness (USFDA/MHRA/EU GMP), assist validation, and train staff; strong cGMP compliance expected.

Qualifikationen

• Diploma/ITI holders should have hands-on experience in sterile manufacturing environments.
• Degree holders should oversee compounding, filtration, aseptic filling and terminal sterilization lines per BMR/SOP.
• Familiarity with cGMP, GDP and ALCOA+ Data Integrity is required.

Aufgaben

• Diploma & ITI holders: operate and monitor sterile manufacturing equipment, perform CIP/SIP, ensure aseptic behavior and line clearance before batch start, log parameters.
• Degree holders: supervise daily operations, ensure BMR/SOP adherence, manage QMS activities, support audits, assist validation and train staff.

Kenntnisse

Equipment Operation

Machine Setup & Changeovers

CIP/SIP Cycles

Cleanroom Compliance

Line Clearance

Equipment Maintenance

Basic Logging

Ausbildung

M.Pharm.

B.Pharm.

Diploma

ITI

Jobbeschreibung

Role & responsibilities (Diploma & ITI Holders): -

• Equipment Operation: Hands-on operation and monitoring of sophisticated sterile manufacturing machinery, including:
  • Vial/Ampoule/Cartridge Washing and Dehydrogenation Tunnels.
  • Aseptic Filling & Sealing/Capping Machines (including Isolator and PFS / Pre-Filled Syringe lines).
  • Lyophilizers (Freeze Dryers) and Autoclaves (Steam Sterilizers)
• Machine Setup & Changeovers: Independently handle machine assemblies, setup, size parts adjustment during product changeovers, and regular startup activities.
• CIP/SIP Cycles: Execute Clean-in-Place (CIP) and Steam-in-Place (SIP) operations for compounding vessels, filtration systems, and filling lines.
• Cleanroom Compliance: Maintain strict aseptic behavior, personal hygiene, and gowning protocols necessary for working inside Grade A/B sterile zones.
• Line Clearance: Perform meticulous cleaning, sanitization, and line clearance protocols before commencing any batch operations. [1, 2]
• Equipment Maintenance: Perform routine preventive maintenance, quick troubleshooting of mechanical/electrical faults, and log equipment breakdowns.
• Basic Logging: Record equipment parameters, process timings, and maintain exact equipment logbooks online.

Role & responsibilities (For Degree Holder): -

• Supervision & Process Oversight: Oversee the day-to-day operations of compounding, filtration, aseptic filling, and terminal sterilization lines.
• Batch Execution: Ensure that manufacturing batches are executed strictly according to Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).
• Documentation & Compliance: Complete, review, and maintain online documentation including BMRs, Batch Packaging Records (BPRs), and deviation logs while ensuring strict adherence to cGMP, GDP, and ALCOA+ Data Integrity principles.
• Quality Management Systems (QMS): Initiate and manage QMS activities, including handling shop-floor deviations, participating in root cause investigations, implementing CAPA (Corrective and Preventive Actions), and managing change controls.
• Audit Readiness: Ensure the manufacturing area is constantly ready for regulatory audits (e.g., USFDA, MHRA, EU GMP).
• Validation Support: Assist the validation/engineering teams during Aseptic Process Simulation (Media Fills), equipment qualification (IQ/OQ/PQ), and re-qualification cycles.
• Team Guidance: Supervise and train operators, technicians, and junior staff on aseptic techniques, line clearance protocols, and cleanroom behavior.

Preferred candidate profile: -

• Required Experience: - 3 to 8 Years
• Required Educational Qualification: - M.Pharm. / B.Pharm. / Diploma / ITI

Regards,

Human Resources Team

Intas Pharmaceuticals SEZ Plant