Executive/ Sr. Executive Manufacturing Production

Galentic Pharma (i); Gandhidham; Presencial; INR 335.000 - 614.000; Tempo integral

Resumo da vaga

Galentic Pharma (i) invites qualified professionals to join our manufacturing team handling derma and ophthalmic formulations. The role focuses on aseptic processing, media fills, and ensuring cGMP compliance across bulk production and packaging lines.

You will participate in validation activities, maintain GMP records, and support QMS processes like CAPA and deviations while coordinating line scheduling and production upgrades with cross-functional teams.

Qualificações

• Experience in Derma formulations and ophthalmic formulations.
• Knowledge of aseptic processes and media fill activities.
• Experience in planning and scheduling manufacturing/packing across lines.
• Ensures line operations comply with cGMP standards.
• Experience in validation activities and GMP records review.

Responsabilidades

• Plan and schedule manufacturing/packing across lines.
• Ensure line operations conform to cGMP standards.
• Participate in validation activities per protocol.
• Check GMP records and junior-filled records.
• Prepare and review batch manufacturing/packing records for QA.
• Work on E-BMR and E-Log Book projects for production upgrades.
• Handle QMS activities like change control, CAPA, incidents, and deviations.
• Knowledge of SCADA systems and packaging/production equipment.

Conhecimentos

Derma formulations

Ophthalmic formulations

Aseptic processing

Media fill

Production planning

cGMP compliance

Validation activities

GMP records

QMS (CAPA/Deviation)

SCADA awareness

Ferramentas

SCADA systems

ADAM

IWK

Trace system

IMA PG

OMAG

Sachet filling machine

Norden filling machine

Autoclave

Descrição da vaga

1.Experience in Derma Formulations, Like Cream, ointment, gel Lotion etc. (Applicable for Non- Sterile)

2.Experience in ophthalmic Formulations, Like eye ointment, eye Gel etc. (Applicable for Sterile).

3.Know the aseptic Process and behaviors/Practices. (Applicable for Sterile).

4.Know and participated in media fill activities. (Applicable for Sterile).

5.Plans/ Schedules manufacturing /packing activities across the month, over various lines along with execution

6.Ensures, on regular basis, that line operations are in conformance with cGMP standards

7.Participates in validation activities as per protocol.

8.Checks the GMP records and checking the records filled by juniors.

9.Fills and checks completed (Batch manufacturing /packing record) before submission to QA.

10.Working on E-BMR, E-Log Book project for upgradation of production activities.

11.Handling QMS activities like change control, CAPA, incident, deviation.

12.Knowledge of SCADA system, in various manufacturing OEM equipment, like ADAM, IWK (High speed robotic tube filling machine), trac & trace system, IMA PG, OMAG, Sachet filling machine, /auto cartonator, Norden filling machine, Autoclave.