1 Opening(s)
2.0 Year(s) To 5.0 Year(s)
3.00 LPA TO 5.50 LPA
Role Purpose: This position is responsible for Handling Maintenance General shift activities and to ensure properPreventive maintenance activities and monitoring the systems are carried out on time to ensure the smoothrunning of PlantsSKILLS:1. RCA, CAPA and 8D analysis2. RCM study3. Troubleshooting
KNOWLEDGE:1. Machine maintenance and breakdown maintenance2. PM planning and scheduling3. ...
1 Opening(s)
3.0 Year(s) To 5.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Finding business partner for plant In-Licensing.
Introduction of New Third Party and Loan Licensing (Out Licensing)
Having contacts with Formulation suppliers of various dosage forms.
Knowledge of transfer price negotiations, current API rate of all dosage forms.
To handle QA activities of Loan License / P to P sites ...
1 Opening(s)
14.0 Year(s) To 25.0 Year(s)
10.00 LPA TO 18.00 LPA
Ensuring compliance to cGMP, GDP for plant operations
Review and compare global quality policies, procedures and directives and regulatory guidelines with site procedures. Identify gaps and ensure updation of site procedures.
Successfully managed Regulated and Semi-regulated market audits
Drive team to productivity and reduce attrition rate; capable of sourcing candidates for own team in minimum timeline
Tracking and investigations of OOS / OOT from manufacturing site on timely manner
Checking compliance of response given to regulatory observation and queries
Review and approve standard operating procedures, specification, master plans, standard testing procedure, protocols and reports
Coordination with manufacturing, purchase, regulatory and R&D for smooth and timely execution of exhibit and commercial batches and new product launches.
Review and completion of change controls of products, process, test method, equipment and facilities.
Respond to inspection observation and business affiliate queries. Provide updates to regulatory agencies on compliance to response.
Drive internal audit, ensure compliance to schedule and timely CAPA implementation.
Approve risk management protocols and reports pertaining to various quality systems
Organize and lead team to execute timely batch processing through validation and checks
Manage and respond to market complaints adequately
Perform Risk analysis and management at regular intervals
Have proven ...