Pilot plant ankleshwar

Experience: 2 to 6 years

Location: R&d; - Api Ankleshwar|api R & D Ank., Ankleshwar, Gujarat, India

Skills: M.Sc (Industrial / Organic chemistry), B.E (Chemical), cGMP, SAP, pH Meter, weighing balance

Qualification
M.Sc (Industrial / Organic chemistry) / B.E (Chemical)

Experience required
2 to 6 years

Role
Sr. Scientific assistant / Research Associate

Note - Person who can join within 2 months will be more preferable.

To ensure that training is acquired for each activity/equipment prior to its execution/operation and that it is as per respective TNI.
To follow the entry and exit procedure of the manufacturing blocks including chemical and Pharma areas.
To perform all process operations as per BMR.
To clean all equipment’s as per cleaning SOP, Procedure and PCR.
To follow all cGMP requirements in the Plant.
To operate all operations as per Safety requirements.
To discuss and get updated for the ongoing and completed operations during the shifts and take the appropriate charge handover.
Review/verify the status of all the equipment and other activity logbooks.
To review and ensure the housekeeping and sanitation of the areas.
To conduct the cGMP & safety talks to the department employees.
Verification of raw materials, packing materials, intermediates that are issued by Warehouse.
Segregation of the raw materials, packing materials, intermediates in the manufacturing storage areas.
Ensure the equipment /area status board updation after operational activities.




Performing the visual cleanliness verification of the operational equipment before starting the operation.
Operate the equipment’s but not limited to, like reactor, filtration equipments, dryers, powder processing equipment.
Charging and discharging of materials as per the approved batch manufacturing records.
Sampling of in process and intermediates and sending the samples to QC for analysis.
Packing and labelling of intermediates, drug intermediates and drug substances.
Operation of utility systems as per the requirement.
Calibration/verification of instruments like pH Meter, weighing balance.
Ensuring the completion of preventive maintenance and calibration of equipment and its accessories as per the defined schedule.
Ensuring completion of the general /breakdown maintenance and permit system as per the requirement.
To ensure that the solid and liquid wastes are disposed off, along with its documentation.
Ensure completion of performance qualification /verification of the equipment as per the requirement.
Preparation of the batch manufacturing records, cleaning records as per process development report.
Preparation of Bill of materials.
Creation of process order in SAP for the raw materials, packing materials as per the requirement for batch processing.




Preparation of the material requisition slip for the issuance of raw materials, packing materials as per the requirement.
Getting issued the batch manufacturing and cleaning records from QA as per the planning.
Online filling of the batch records during the execution of the activities.
Recording of different activities in the respective logbooks as per the defined procedure.
Review of the batch records after completion of the activities.
To ensure that the completed batch records are submitted back to QA for review and archival.
To comply the review observations by QA in the batch records.
To verify the equipment and areas before line/area clearance activities and witness the clearance.
Generation of the in process and other status labels and affixing the same as per defined procedure.
To report the final output(yield) in SAP.
To perform the activities related to preventive/general/breakdown and calibration in SAP.
Comply with the cGMP & safety norms.
To acquire trainings on the SOPs, batch records and provide training to the subordinates as applicable.
To participate in internal, customer and regulatory audits.
To perform any other activities as assigned by HOD after completion of the necessary trainings as applicable.
To escalate any issues related to discipline, availability of manpower, hygiene, contamination, cross contamination, Incidents or deviations, malfunctioning of equipment’s, any unusual observations, any safety risk or quality risk to next level or in absence further up.

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