Executive TO Manager - Oxalis Labs (Macleods Pharma) - Baddi
(2012-02)
- Review and approve equipment qualification to ensure compliance with specifications and validation requirement
- Conduct employee training (Through PLMS) and evaluation through on-the-job instruction and practical equipment demonstrations
- Preparation and review SOPs (through DMS) for related equipment's and procedures
- Raising (through ERP), review of requisition for the requirement of consumables items and check on its inventories according to their approved budget
- Implementation of quality management system as per cGMP and international standards
- Implementation of corrective and prevention action (CAPA) for non-conformances and self-inspection findings
- To exercise affective control over environmental condition in manufacturing and other related activities which may adversely affect the product quality
- To coordinate and approve calibration/maintenance of all production equipment's and instrument with engineering/QA/QC and outside agencies
- To carry out routine documentation per regulatory requirements
- Adhere to specified working hours
- To ensure and maintain cleanliness of production area and equipment as per SOPs
- Coordination with production, PPIC QC CQA, QA, Engineering and other smooth production activities
- Organize the job responsibilities to the technician, officer, executive as per plan and manage absenteeism
- Verification of dispensed RM/PM against production plan
- Continues monitoring of in-process control in all production areas and improve daily production
- To fill maintain and approve batch record online
- Evaluate and sign production records before QA submission
- Capable of handling more than 100 man-power/resources
- Adopting latest technology in production and packing lines (track and trace system, 2D coding)
- Ensuring the risk assessment for new product and existing products
- Ensuring Zero non-compliance and zero data integrity in documentation
- Handled change control, deviations/events, CAPA, OOS, and OOT activities through Track Wise to ensure regulatory compliance
- Managed end-to-end activities across Production and Packing departments to ensure efficiency and compliance
- Managed end-to-end production operations to ensure timely achievement of production targets based on rolling forecasts and availability of machines and materials
- Supervised overall shop floor activities and implemented effective techniques to improve operational efficiency and achieve cost savings
- Planned and optimized manpower and machine utilization through effective resource planning
- Coordinated with R&D for planning and execution of exhibit batches
- Conducted training activities through the PLMS system
- Reviewed and authorized production and stores SOPs and work instructions, ensuring strict compliance
- Ensured production records were reviewed, evaluated, and signed prior to submission to Quality Assurance
- Conducted risk assessments through FMEA and HACCP to identify and mitigate process risks
- Performed process variable impact analysis to assess the effect of critical parameters on product quality
- Prepared, reviewed, and verified monthly WIP statements and yield reports to ensure data accuracy
- Reviewed and approved manufacturing, filling, and packing protocols for Cream, Ointment, and Lotion products, along with evaluation of Process Validation reports
- Ensured timely planning, execution, and compliance of qualification and validation activities in accordance with regulatory requirements
- Computer System Validation (CSV) - DQ, IQ, OQ, PQ execution
- Designed and implemented systems, processes (BMRs and protocols), and procedures (SOPs) to ensure smooth production operations and improve overall operational efficiency
- Identified and optimized key process parameters while initiating process improvements to meet productivity and profitability goals
- Performing the functions of trouble shooting and breakdown, preventive, corrective and routine maintenance for reducing machinery down time to minimum and maximum utilization of machine
- Maintaining & control of consumables spare parts to facilitate smooth execution of projects
- Work profile across Semi-Solid Manufacturing and Packing Departments during project execution
- Conducted Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) for production and packing machinery
- Managed machine installation and ensured completion of qualification documentation
- Executed and documented DQ, IQ, OQ, and PQ activities in compliance with CSV and GMP requirements
Officer -production - Indchemie health specialties Pvt. - Baddi
(2010-02 - 2012-02)
Executive-production (Liquid, Ointment) - M/S Three B Health Care Ltd. - Paonta-Sahib
(2007-08 - 2010-02)
Officer –Production (Oral Liquid) - Akums Drugs Pharmaceutical Ltd. - Haridwar
(2004-06 - 2007-08)
