Job Responsibility for Engineering
Job Summary
To plan, organize co-ordinate and control daily activities related to Engineering as per laid down procedures and
systems. He is responsible for all below mentioned activities:
Job Responsibility
The following shall be the principle duties and responsibilities of Engineering Manager deputed in the Plant.
1. Responsible for overall activities of engineering & maintenance of plant machineries, utility equipments etc.
2. Responsible for overall day to day activities of operation of plant machinery & utility.
3. Responsible for any expansion and modification of plant and machinery as per cGMP requirement.
4. Responsible for breakdown and any procurement of spares and change parts for machineries.
5. Responsible for maintenance of building & premises.
6. Responsible for preparing the list of spares and maintaining of their stocks.
7. Responsible for preparing the budget for engineering and maintenance activities and reduction of utility cost.
8. To review daily maintenance report, compare with the plant preventive maintenance schedule and observe
for any deviation from plan. If any deviation are observed, implement preventive action for the same.
9. To Co-ordination with inter department activity day to day.
10. To interact with plant teams effectively & support the regulatory audit & requirements.
11. To maintain all documents related to engineering services in order & Communicate effectively
with regulatory authorities.
12. To assure the utility operations and record the activities in log book.
13. To assure GMP norms and SOP compliance.
14. To monitor the machine maintenance activity across the plant.
In the absence of candidate suitable person will be deputed to perform the above activities by HOD.
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
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process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
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Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
Cleaning Validation of Equipment
Measurement and Recording of Temperature and Relative Humid
Sampling of Product at Intermediate Stages
Approval of Overprinting on Packing Material
sop for Procedure for Reprocessing
Preparation and Control of Master Batch Production and Control record
Issuance and Retrieval of Control documents
Calibration Policy for equipment
procedure for batch numbering system for products
sop for Handling of Incident during operation
Procedure for Allocation of Numbers for Machine Equipment
Validation and Qualification Facility System and Equipment
In-process Checks During Packing Operation
Operation and Calibration of Leak Test Apparatus
Operation and Calibration of Friability Tester
Access to Authorized Persons in Critical Areas
Operation Cleaning and Calibration of Digital Vernier Caliper
sop for Sampling Procedure for Finished Product Samples
Job Responsibility for Engineering
