Working as a team leader to meet new standard and requirement of FDA to meet compliance for data integrity in production
To performed manufacturing investigation related to OOS/OOT/Deviations/any other shop floor incidences
Facilitate PDL/TS team for manufacturing of scale up, exhibit & validation batches
To Perform the SAP/ERP transaction's for daily activity like Indenting, stage wise conformation etc
Ensure tooling/change part availability for products at various stage
Ensuring accomplishment of C Vs
A with quality product delivery; managing overall operations involved in production planning
Overseeing production of various drugs and implementing plans with a view to ensure timely accomplishment of production targets within the cost parameters
Facilitating process implementation of all production activities
Ensuring complete in-process quality control and continuous improvement in process capabilities
Formulating standard operating procedures for new processes for ensuring environment, health & safety aspects
Guiding staff, monitoring the performance of team members to ensure efficiency in process operations and meeting of production targets
Creating and sustaining a dynamic environment that fosters development opportunities and motivates high performance amongst team members
Methodical analysis of Monthly data review related to yield improvement and time saving in Granulation, Compression, Coating and Capsule Filling during operation and cleaning
Preparing Monthly plan and achieving monthly production target through Successful execution of daily/monthly Plan
Responsible for ensuring strict compliance to the current regulatory guidelines, quality standards & continuous improvement in quality
Effective Utilization of Equipment by reducing number of cleaning and producing highest quantity of product in limited time with quality
Reutilization of change parts by modification to reduce operating cost and providing training to associates and operators for best possible way of using change parts
Providing training to juniors about machine assembling and techniques of yield improvement
Deals with problem related with the machine and product setting in korch XL-600,Fette, Legacy6100, Sejong ventix, Sejong HRC series and CTX compression machine
Handled sophisticated machines such as RMGs, FBEs, Glatt Coater 60'', ACG SC-1000, ACG SC-350, Korch XL-600, Sejong HRC series and Fette 3200 i, Legacy 6100 Compression machine
Maintaining the inventory level of finished goods and WIP
Managing Change Controls, Deviations, In-process Failure, Line Clearance Failures and SOP's
Sustaining and analyzing monthly productivity reports
Ramping order establishment of different products (This is the process optimization project)
Executing & streamlining other day-to-day activities which include: Organizing brainstorming sessions with shop floor personnel to find out the gaps
Implementing Six Sigma and TPM (Total Productive Maintenance)
Ensuring to comply to EHS obligations in the department
Managing deviations, change control, CAPA and market complaints through Caliber QAMS Software
Verifying & approving BMRs through SAP, & Purchase Requests
Ensuring the organized upkeepment of the department
Conducting recruitment and tracking the progress of new recruits
Spearheaded production, validation, training and manpower planning; collaborated with other departments for developing day-to-day production plans
Worked closely with warehouse and quality control department for availability of raw & packaging material and consumables