Junior Officer, QMS
Job Description
•To follow the safety rules in the premises according to the company norms.
•Timely completion of SOPs training and On the job trainings related to visual inspection and packing
area.
•Monitoring of DP, RH and temperature area in their visual inspection and packing area.
•Responsible for Maintenance of cleaning in visual inspection and packing area.
•To maintain the BMRs and other log books in the visual inspection and packing area as per cGMP and
SOP.
•Operation and cleaning of dynamic pass box.
•Responsible to perform the in process checks during operation.
•Responsible for Operation and Cleaning of Wrap around labeling machine, Autocartonator machine,
Online check weigher, track and trace system, Bopp taping machine with weighing balance and PFS
packing area machines.
•Responsible for labeling and packing of products as per BPR.
•Operation and cleaning of visual inspection table and Operation of Lux meter.
•Responsible for Operation and cleaning of Automatic visual inspection machine and X-RAY inspection
machine.
•Responsible to perform visual inspection of the products /media filled vials or PFS as per the sop.
•Responsible for the co-ordination with cross functional departments like QA,QC, warehouse Engineering
,HR and administration for the day to day activities.
•Responsible for timely completion of calibrations and validations in coordination with EN and QA related
to visual inspection and packing area.
•Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by
following HODs instructions and guidance.
•To prepare BMR and BPR.
•Preparation and periodic revision of SOPs related to QMS area.
•Responsible for intra and inter coordination with different functions.
•To participate in Regulatory & Customer Audits.
•To perform Gap analysis of defined procedures in Batch Manufacturing Record / Batch Packing Record /
Standard Operating Procedure / Protocol and initiation of corrective actions.
•To prepare and review of Standard Operating Procedures / Protocols.
•To perform risk analysis for different process or procedures and implement necessessory mitigation plans
through Quality Risk Management (QRM).
•To prepare Failure Investigation Reports against Quality impacting deviations, Out-of- Specifications and
Non-Conformances.
- Diploma DBM - Required
- Bachelors Degree (BA/BS) B. Sc. - Preferred
- 2 years or more in 2 - 5 Years