- Maintain quality system controls to ensure state of compliance and no critical and major market complaints.
- Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
- Act as Quality representative on the floor during manufacturing operations and assist Production personnel with troubleshooting.
- Perform Aseptic Gowning successfully.
- Perform daily compliance walk-throughs in Production and Warehouse.
- Perform release of rooms for Manufacturing and Packaging.
- Assure release of raw materials and components prior to manufacturing.
- Control and maintain product labels.
- Maintenance of reserve sample / retention samples / control samples storage.
- Providing Quality Support during Validation, Cleaning Verification, In-Process Sampling.
- Performing Real-Time Batch Record Review.
- Initiate and aid in the investigating of Incidents and Deviations.
- Perform Root Cause Analysis using tools such as Fishbone, KT, 5Whys, etc.
- Develops applicable Standard Operating Procedures (SOPs) governing Quality Management Systems.
- Supports regulatory inspections and audits.
- Communicate results from Daily Compliance walkthroughs.
- As appropriate, use knowledge and experience to solve straightforward problems.
- Ensures Operations are compliant with SOPs.
- Use independent judgment, as necessary, in developing systems/processes for use within Quality.
- Aid in the identification of Process Improvements on a continuous basis.
- Aid in the monitoring of Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
- Good communications skills, front runner.
- Line clearance of all the products manufacturing in the shop floor.
- Review of Batch Manufacturing Record and other documents pertaining to the master documents of the company.
- Monitoring of all the in-process activities of the manufacturing processes going in the shop floor.
