Job Description

Title



Shift Chemist - Pharma





Department



Manufacturing





Sub Department



Production

PURPOSE OF THE ROLE

Responsible to achieve the desired production yield of pharmaceutical APIs by carrying out all the production activities in the shift in compliance with cGMP, cGLP, EHS requirements and specified operating procedures.

JOB DESCRIPTION

(What the person needs to deliver at workplace)



Proper takeover of shift operations as per defined procedure as a reliever. Batch Manufacturing Process :
+ Follow Gowning Procedure before entering pharma area at cross over bench.

+ Indent raw materials from stores and update balance in Material Reconciliation Record.

+ Collect Intermediate material from Intermediate area.
+ Ensure availability of Utilities before charging the batch.

+ Verify and charge raw material quantities, Intermediate material, execute production process and record process parameters progressively in Batch Manufacturing Sheet.
+ Participate in cleaning and process validation during batch startup process.

+ Carry on Filtration Activities (Leaf Filter, Pressure Filters and Micron Filters).

+ 100% adherence to cGMP practices in line with 21 CFR.
+ 100% adherence to EHS requirements as applicable to production shop floor.
+ Maintain Housekeeping and Hygiene in shop floor area in line with specified procedure.
+ Ensure Pest Control in shop floor area.

+ Dispense required samples to QC in line with specified procedure.
+ Perform packing activity and dispense finished material to stores for dispatch in line with specified procedure.

+ Timely reporting of abnormalities/ deviations to the immediate supervisor/ appropriate authority.
Documentation activity :
+ Live recording of each activity in Batch Manufacturing Sheet and other records such as cleaning record, material reconciliation record, reactor logbook, etc.
+ Handover completed documents to Shift Incharge / ongoing documents to reliever.
Maintenance activity :
+ Provide required support to plant maintenance staff for preventive maintenance schedules.

+ Coordinate with plant maintenance team for ensuring temperature and pressure and humidity and to resolve breakdowns during the shift.
Training :
+ Successful completion of assigned trainings and application of the same at workplace.

QUALIFICATIONS/ EXPERIENCE REQUIREMENTS

Parameter

Minimum

Preferred

Education



B.Sc. (Chemistry)



M.Sc. (Chemistry)





Experience (in Years)



2



4





Nature of Experience



Knowledge of production and quality systems, regulatory and cGMP guidelines, EHS requirements in Pharmaceutical API companies.

COMPETENCY REQUIREMENTS

#

FUNCTIONAL

Ability to understand systems and processes





Execution





Optimum Utilization of Resources

BEHAVIOURAL

Attention to detail





Teamwork





Problem Solving