Job Title: Assistant Manager - Quality Assurance
Competencies
Purpose of Job
EPIC Q.A.
Responsible for implementation & monitoring the EPIC Circle, Best Practice Campaign, communication campaigns, Rewards and Recognition and Golden Treaty as cross-functional team mutually agreed SLAs through continuous improvement and transformation quality culture at shop floor and lab floor at Intas Pharmaceuticals Ltd. Biopharma site
Skill Required
- To conduct training to metric owner/Circle owner/mentor on quality circle huddles.
- To conduct training to NHO (New hire on board) on simplified ‘bite-sized learning content of EPIC program.
- To Attend and evaluate each Circle having QDSHIC (Quality, Delivery, Safety, Health, Ideas & Compliance) Observation, Challenges, Action sheet Tracker and Deviation Log for which the details maintained shift wise by respective Circle owners.
- To Prepare and circulate Do’s and Don’ts, Best-practices on key Quality-critical themes.
- To assess EPIC circle to evaluate the performance of respective EPIC Circle.
- To ensure that filled pages / template from the respective EPIC Circle and its maintain Excel sheet tracker and retrieve from respective EPIC Circle owner after completion of every month.
- To monitor and handling filled pages / template of respective EPIC Circle and destroy as per QA SOP.
- To Prepare Data integrity/ Good Documentation Practices/cleaning sanitization/labelling booklet or any other subject as per requirement as a training module and circulate in the respective departments at quality circle for ensuring best practices.
- To conduct and handling with Nukkad Natak (skit) bus quizzes or any other activity to drive retention on key messages and Rewarding employees for quizzes, competitions & demonstrated behaviour to test effectiveness.
Roles and Responsibilites
- To monitor and evaluate Role-model behaviour by leaders via direct interactions during Gemba Walks, Quality circle huddle and activate key messages and Gemba adherence tracker sheet is regularly updated across site.
- To ensure monitoring and adherence to implementation plan Communication tracker.
- To ensure that Cross-functional team mutually agreed SLAs as Golden Treaty through continuous improvement and monitoring to comply to the expectations of the other function.
- To prepare weekly report of Epic Circle/Gemba Walk/Golden Treaty/Best Practice Campaign/Recognition and Reward for continuous improvement at shop floor and Lab floor.
- To prepare, Review of SOP/Protocol as and when required for the respective area/process.
- To Provide support to EPIC site SPOCs in de-bottlenecking issues
- To follow ‘Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.
- To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed.
- To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description.
- To ensure that, In case of any event of potential data breach, it shall be handled through SOP on ‘Handling of Potential Data Integrity Observation’.
- To Report Site Lead- if any Discrepancy found in Quality circle/Golden Treaty/Best practices campaign/Gemba Walk and communications
Qualification Required
M.Pharm
M.Sc/M.Tech
Relevant skills / Industry experience
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213