Name
Qualification
Total Experience
7
Employee Code
ACS Code
Designation
Department
Production
Date of Joining
Reports to
(Position)
Sr. Manager
Revision No.
Effective Date
Accepted by
Job Holder
Designee
Department Head
Head HR
Sign
Date
Name
FORMAT NO.: QAC-205/F02-03
Page 1 of 2
1.
Online completion and submission of batch records and respective documents time to time with GDP, no
delay should be there due to pendency in respective documents.
2.
Monitoring and control batch wise yield, process breakdowns & rejections.
3.
Requisition for monthly documents and Preparation BMR with filling details.
4.
Monitoring of Issuance, preparation and filtration of disinfectants.
5.
Responsible for In-process checks Filling activity.
6.
Fogging & cleaning activity of filling area & also D-Area in Block -E.
7.
Responsible for Batch filling planning with ready BMR for filling and dispensing activities of primary
packing, material time to time.
8.
Decisions of Shop floor obstacles at right time in coordination with IPQA in-charge and maintenance in
charge.
9.
Responsibility to achieve monthly production target through successful execution of monthly plan,
minimize rejection at various stages.
10.
Monitoring of EQMS related Activity.
11.
Compliance of SOPs.
12.
Maintain D.P. & temperature records.
13.
Monitor and control the sterile area activities time to time.
14.
Follow cGMP strictly on shop floor to maintain discipline.
20CHANDRA
AKUMS DRUGS & PHARMACEUTICALS LTD.
PLANT-III, HARIDWAR
QUALITY ASSURANCE
JOB DESCRIPTION
Name
Qualification
Total Experience
7
Employee Code
ACS Code
Designation
Department
Production
Date of Joining
Reports to
(Position)
Sr. Manager
Revision No.
Effective Date
Accepted by
Job Holder
Designee
Department Head
Head HR
Sign
Date
Name
FORMAT NO.: QAC-205/F02-03
Page 2 of 2
15.
Observation and Noncompliance w.r.t. quality of batch and documentation should be controlled for better
control.
16.
Monitoring of CIP and SIP of manufacturing and holding tanks and transfer lines
17.
Line clearance to start any line operation of Manufacturing Area.
18.
Aseptic filtration of Batch manufactured after QC release.
19.
Monitoring of Electronic data recording in SAP/LIMS4.5 for different stages of Batch Manufacturing.
20.
Up-keeping of areas for cGMP audits and visits
21.
Follow up inter and intra department for reducing the breakdowns and smooth production activity.
