Job Description

Designation: Sr. Executive Production

Followings will be the Core Job Responsibilities of the position holder:

1.    To initiate Change Control, planned deviations and perform impact assessment.
2.    To identify the process improvement scops and implementation of identified gaps.
3.    To perform manufacturing investigations related to deviation / OOS / OOT and market complaints to identify the root cause and implementation of appropriate CAPAs.
4.    Review of non-conformances, deviations, change controls, internal audits, annual product quality reviews and to perform assessment on other impacting documents and related activities. 
5.    To analysis the manufacturing/packing process and analytical data for investigational aspects.
6.    To review APQR data to identify product and process capability and improvement scopes.
7.    Handling of QMS activities in Trackwise software. 
8.    To perform quality risk assessment and participate in Quality risk management exercises.
9.    To perform the gap analysis with respect to cGMP guidelines, current regulatory requirements, and SOPs, wherever required and to comply with the requirements and implement the same.
10.    To ensure proper training to all the concerned personnel with respect to investigation outcomes.
11.    To ensure compliance at shopfloor with respect to SOPs.
12.    Preparation and review of Standard Operation Procedure.
13.    To follow the environmental, health and safety policy of organization.
14.    Should have experience in MS&T or Production QMS and should have sound knowledge of tablets/ capsule manufacturing process and challenges.