Job Description

Department Details
Role Summary
JUNIOR ASSOCIATE (PROCESS EQUIPMENT)
Role 1 Site L2 -EM DS- Operation - Team (2700-OPERATIONS-DRUG SUBSTANCE-35836)
Role 1 Training
1) To communicate with external vendor for site services/repair
2) To liaise with EHS for any document related or permit registration/LOTO/ect
3) To coordinate and ensure training is imparted to external vendor
4) To attend, record and conduct all trainings required as per training matrix/ schedule.
5) Fill log sheets/ checklist/ planner as described in the SOPs.
6) Issue of work permits and gate pass.
PM
1) To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime.
2) To raise communication memo for Preventive Maintenance.
3) To respond, carry out and record equipment maintenance activity effectively and efficiently.
4) Ensure all equipment is operating and maintained as per manufacturer's recommendation.
Operation
1) To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part.
2) Observation, troubleshooting and rectification of equipment/ machines condition and detection of unusual conditions in a proactive manner.
3) Daily reporting of activities and updating any issues at work to the superior.
4) Fill log sheets/ checklist/ history card/ planner as described in the SOPs.
5) To learn and practice SAP for the following activity such as raise, address and close notifications/work orders.
Qualification
1) Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. Generate various document procedure/protocol/report as and when required.
2) Participate in project activity on process optimization, facility upgrade, or objective
Role 2 Site L2-EM DS - Mandatory Annual Training (2700-OPERATIONS-DRUG SUBSTANCE-45309)
Role 2 1) 1)To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
2) Employees who are involved in GMP activities should undergo a mandatory cGMP training.
3) Frequency of mandatory basic training is once in a year
4) All employees that involving with GxP environment should undergo a mandatory basic microbiology training
5) To provides information, guidance and recommendations to facilitate compliance with DI, GDP in documentation.
6) To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
Key Responsibilities
JUNIOR ASSOCIATE (PROCESS EQUIPMENT)
Role 1 Site L2 -EM DS- Operation - Team (2700-OPERATIONS-DRUG SUBSTANCE-35836)
Role 1 Training
1) To communicate with external vendor for site services/repair
2) To liaise with EHS for any document related or permit registration/LOTO/ect
3) To coordinate and ensure training is imparted to external vendor
4) To attend, record and conduct all trainings required as per training matrix/ schedule.
5) Fill log sheets/ checklist/ planner as described in the SOPs.
6) Issue of work permits and gate pass.
PM
1) To carry out planned preventive maintenance on all plant and equipment aiming to achieve maximum plant availability with a target of zero unplanned downtime.
2) To raise communication memo for Preventive Maintenance.
3) To respond, carry out and record equipment maintenance activity effectively and efficiently.
4) Ensure all equipment is operating and maintained as per manufacturer's recommendation.
Operation
1) To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part.
2) Observation, troubleshooting and rectification of equipment/ machines condition and detection of unusual conditions in a proactive manner.
3) Daily reporting of activities and updating any issues at work to the superior.
4) Fill log sheets/ checklist/ history card/ planner as described in the SOPs.
5) To learn and practice SAP for the following activity such as raise, address and close notifications/work orders.
Qualification
1) Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. Generate various document procedure/protocol/report as and when required.
2) Participate in project activity on process optimization, facility upgrade, or objective
Role 2 Site L2-EM DS - Mandatory Annual Training (2700-OPERATIONS-DRUG SUBSTANCE-45309)
Role 2 1) 1)To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
2) Employees who are involved in GMP activities should undergo a mandatory cGMP training.
3) Frequency of mandatory basic training is once in a year
4) All employees that involving with GxP environment should undergo a mandatory basic microbiology training
5) To provides information, guidance and recommendations to facilitate compliance with DI, GDP in documentation.
6) To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
Educational Qualifications
Required Education Qualification: B.E
Required Experience: 4 - 9 years

Skills Required