Amanpreet K. Email and Phone Number

-Supervises all packaging employees working on multiple production lines on an assigned shift.-Maintains work flow and oversees packaging line by monitoring steps of the process, including packaging validation activities-Completes production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results of the processing flow on shift production summaries-Ensures that necessary materials and components are available for each scheduled line, and may assist other supervisors in determining the movement of materials and products to/from machine centers, and changes machine schedules to maximize production-Ensures that Good Manufacturing Practices (GMPs) are maintained by staff through the effective use of Standard Operating Procedures (SOPs). Ensure all personnel receive and complete GMP and skills training as required-Ensures operation of equipment by calling for repairs and by placing Manufacturing Request Form-Coordinates with Warehouse associate ahead of time to ensure issuance of all packaging components are correct for scheduled runs-Ensures that packaging work order are thoroughly reviewed and forward to production coordinator -Helps assisting Quality for Customer queries on packaging process and documentation.-Initiates investigations related to non-conformances and customer complaints. Initiates planned deviations and production change controls related to the packaging processes. Ensures corrective actions (CAPA) are executed as outlined in planned deviations, incident reports/investigations and customer complaints.- Initiates Change Control in Trackwise to update packaging work order- Leads continuous improvement projects in the Production Department-Responsible to ensure Health and Safety measures been taken by all the personnel in department- Involves in recruitment process, candidate selection and orientation of new employees etc

- Generates and reviews Raw Materials, Bulk and Finished Product Specifications to support the inspection, testing and release of Raw Materials, Bulk and Finished Products.- Maintain the approved Raw Materials, Bulk and Finished Product Specifications in the Portal. Generates RFA when approved Specifications is not available.-Support Analytical Method Transfer Strategies by generating Method Transfer Assessment (MTA). Review Method transfer and Method Validation protocol and reports.- Creates list of Raw Materials impacted with USP and EP updated, initiates Change Controls in Trackwise for revision of Raw Materials Specifications.- Executes Change Controls assigned for Bulk and Finished Product requested by the customer.- Evaluates and assesses the Supplier Change Notification (SCN), performs the final assessment and closure of SCNs.- Ensures approved Raw Materials, Bulk and Finished Product Specifications are available on time for sampling, testing prior to the fabrication of bulk and finished product.- Where required, documents or reviews and approves Planned Deviations. Develops CAPAs and follows up on CAPA closure. -Collaborative working with labs, internal and external customers.

- Analyzes reviews and approves all executed manufacturing and packaging batch records for compliance to regulatory specifications, customer requirements, and internal cGMP procedures and systems. - Assembles all batch records to ensure all the documents required for product release are present. Follows up to obtain any missing documentation.- Reviews and approves laboratory results for bulk product and finished product to support final release for shipment.- Generates and approves product Certificate of Analysis (COA) or Certificate of Conformance (COC) as required. - Approves release of batches based on review of successfully executed batch records.- Assists the Investigation Team on Incidents and Out-of-Specification (OOS) results for bulk product and finished product to identify root cause and corrective action and to determine the effect on product quality.- Establishes bulk and finished products are released in a timely manner to meet customer requirements.

- To Perform and document formal line clearance and start up approval.- To Monitor manufacturing and packaging operations to ensure that all activities are in compliance with the approved Work Order, SOPs and GMPs.- To Provide both formal training and ad-hoc guidance in collaboration with the Production supervisors to enhance GMP understanding and promote good documentation practices.-To make Quality decisions regarding manufacturing and packaging issues asrequired according to SOPs. Ensure quick escalation of significant issues to upper management as appropriate.- To facilitate the appropriate use of Quality Systems and the correct initiation,logging, recording, follow-up and closure of Quality documents (IR, CAPA, etc.)triggered by manufacturing and packaging events.- To assist the Production Supervisors in the performance of second sampling, IRs and investigations.- To participate as a member of investigation teams to assess an incident’s potential impact on product quality, develop corrective action plans to mitigate the impact, identify the root cause and establish the appropriate preventive actions.- To assist in the batch record review process by reviewing manufacturing andpackaging records and related documentation for completeness and correctness at the time of execution for compliance to regulatory specifications, customer requirements, internal procedures and GMP.- To assist in collecting samples and compiling documentation for testing.- To provide support to all areas of the organization by performing other related QA and QC related duties as may be required.

- To assign tracking numbers to Change Control and maintains the logs with relevant information.- To administer the control, including maintenance of the tracking log, for Planned Deviations and associated CAPA. - To track and follow up on CAPA related to investigations and Planned deviations.- To send samples of Bulk and Finished Product to the related Lab(s) for analysis against approved specifications and follow up to ensure test results are received in a timely manner.- To manage and to maintain records of annual inspection of Retain samples, where ever applicable.-To login all the Bulk,Finished product regular and validation samples in LIMS.

1. Ensure all packaging work order (PWO) documentation is complete and accurate. 2. To approve the Line before start up of production of any product (Tablets, Creams, Lotions and Liquids etc.).i) To check the Bulk drum has been identified with bulk tag as per PWO.ii) To ensure equipment or machine used for production(Filler, Pump) has been cleaned with in 24hrs of start up of production. And they have respective cleaned and sanitized tags.iii) To check the work in progress tags on the machines wherever applicable.iv) To ensure all the packaging components are on the floor with dispensing ticket before start up of the production.v) To verify the components with respect to Work Order.vi) To Check the accurate coding (Lot no. and Expiry date) on the Tubes, cartons, labels according to the work order, and sign the two samples as part of approval. 3. Perform production line checks as stipulated on PWO after every half an hour. For e.g. i) To chk the fill wt of creams, lotionsii) To check the Lot no. and Expiry date on the tube and respective carton.iii) To check the appearance of Bulk and packaging material during the run.iv) To check the part number on the Tube, Insert, Label during the run as per PWO.v) To check the accurate quantity of finished products being packed in the shipping cases (corrugated boxes).4. Perform verification of materials to ensure correct part number during the production run.5. To collect the samples at the start, middle and end of the run as per work order.6. Ensure quality, safety and efficiency on their specified production lines as per GMP & Safety standards and reports quality and maintenance issues to be addressed.7. Ensure that the data entered on the Packaging production Report is complete and correct.8. To do the Line waste and Remnants on completion of batch.9. To check the accountability for all the components at the end of run to confirm they are with in the range.10. Other duties as assigned by Shift Lead.

- Supervises, assigns and directs the work to all packaging and manufacturing employees- Responsible for compliance to revised Schedule M and cGMP guidelines as per WHO norms.-To plan, control and execute all manufacturing activities w.r.t. men, material, machines, products and processes.- Responsible for quality and quantity of drugs manufacturing in Capsule, Ointment, Dry Syrup, Tablet and Liquid sections. - To co-ordinate with other departments e.g.QC, QA, Eng., R&D, HRD for effective implementation of operational plans.-To prepare, check and update all the Master Formulas,and SOP's related to Manufacturing and Packaging operations as per GMP including SOP's related all the Machines used in the production.-To ensure timely recording and completion of Batch Manufacturing / Packaging Records during the manufacturing and packaging operations respectively. - To prepare and issue requisition of Raw and Packaging materials with respect to the Batch Size of the product.- Oversees Packaging line by monitoring steps of the process of filling and packaging of Liquid, Ointment, Cream and capsules- Verify packing material for any type of misprinting and error in batch coding and approving them- Oversees Manufacturing line by monitoring steps of the process of manufacturing that includes weighing of raw materials, mixing at different steps (manufacturing Liquid, Ointment, Cream and capsules batches)- Responsible for development of formulations for new drugs and assist in carrying out various studies on new formulations.- To implement current trends which are feasible and valuable for company's system. - To create a healthy and value based management system in manufacturing and packaging for high morale, high productivity and to facilitate self development of the employees.

-Data conversion, Execution, and Testing for Quality Management Module in SAP