Executive/Senior Executive - Production (API)

Solara Active Pharma Sciences; Mangaluru; On-site; INR 300,000 - 420,000; Full time

Job summary

Solara Active Pharma Sciences in India is seeking a production professional to manufacture APIs according to pre-approved BMR instructions, and to ensure batch records and equipment usage logs are completed on line with signature.

You will coordinate with Engineering for maintenance, report any deviations from procedures, document GMP/QMS/EMS activities, manage waste, calibrations, TrackWise uploads, and support timely product delivery.

Responsibilities

• Producing APIs according to pre-approved BMR instructions.
• Ensuring all production batch records, equipment usage log is completed on line with signature.
• Performing the equipment Qualification for new / relocated equipments in the plant.
• Coordinating with Engineering department for ensuring maintenance related works.
• If any deviation observed against established procedures, the same shall be reported immediately to shift in charge/supervisor.
• Cleaning of all production facilities and disinfect when appropriate and record the details in the respective registers with signature.
• To ensure the timely delivery of Products.
• Documentation of cGMP, QMS & EMS related activities .
• Handling of Hazardous and Non-Hazardous waste.
• To prepare and uploading the BMRs/BPRs in Track wise.
• Initiating deviations, change controls in track wise and new product checklist for review.
• Performing the equipment performance Qualification for new / relocated equipments in the plant.
• Coordinating with warehouse regarding raw material requirements.
• Coordinating with Engineering department for ensuring maintenance related works.
• Perform the necessary calibrations and record the details in respective registers with signature Documentation of GMP, QMS related activities.

Job description

Role & responsibilities

• Producing APIs according to pre-approved BMR instructions.
• Ensuring all production batch records, equipment usage log is completed on line with signature.
• Performing the equipment Qualification for new / relocated equipments in the plant.
• Coordinating with Engineering department for ensuring maintenance related works.
• If any deviation observed against established procedures, the same shall be reported immediately to shift in charge/supervisor.
• Cleaning of all production facilities and disinfect when appropriate and record the details in the respective registers with signature.
• To ensure the timely delivery of Products.
• Documentation of cGMP, QMS & EMS related activities .
• Handling of Hazardous and Non-Hazardous waste.
• To prepare and uploading the BMRs/BPRs in Track wise.
• Initiating deviations, change controls in track wise and new product checklist for review.
• Performing the equipment performance Qualification for new / relocated equipments in the plant.
• Coordinating with warehouse regarding raw material requirements.
• Coordinating with Engineering department for ensuring maintenance related works.
• Perform the necessary calibrations and record the details in respective registers with signature Documentation of GMP, QMS related activities.