Sr.Executive- Site Representative- Vikhroli

Responsibilities:

Operation Control and Monitoring Multiple CMO Sites.

• Check Plan Vs Achievement on a regular basis.
• Provide information to Production coordinator daily via Daily Performance report.
• Check availability of resources at contract site to meet schedule.
• Check documents availability in case of change in product.
• Provide batch no. requisition to coordinator as per plan.
• Ensure timely SAP posting and dispatches.
• Monitor Schedule OTIF. OTIF Tracking at respective CM sites, On Time in Full (OTIF) delivery Supply deliveries as volumes committed & requirement.
• To Co-ordinate with Stores and contract manufacturing site for the timely shortages, availability, and release of RMs and PMs.
• Follow-up for release of RM's/PM's & FG as defined times lines.
• Ensure availability of change parts and tooling as per product specification and coordinate for new product launches with New product launch team.
• Planning and tracking deliveries to avoid Loss of Sales/Stock out situation. Follow up with different CM sites for delivery Commitment of current month and material status for rolling month’s plan.
• Implementation & Tracking of Changes if any for Artwork/Packing materials /Quality improvement Changes/MRP etc. for Unit.
• Sorting out the Daily SAP & eMRP portal related issues at site.
• Trouble shooting in production & packing.
• Coordinating for Stock audits and inventory Audits.
• Check practices at contract site for Cipla quality policy.
• Check products manufacturing as per Cipla BMR/BPR
• Check in process checks and machine performance.
• Provide quality observations and check CAPA implementation at CMO’s.
• Check line clearance practices and provide insight to Production coordinator.
• Check BMR/BPR and provide product review sheet to Production coordinator for Batch release.
• Provide packing list in case of export order.
• Review quality of products at CM Sites in compliance with cGMP requirements and Cipla quality policy. Corporate(1035-G-0047/F5/4)
• Review & reporting any noncompliance during routine observation & ensuring the compliance through proper tracking & CAPA.
• Provide training to the location staff and workmen on current Good Manufacturing Practices (need basis) and data integrity Practises.
• Check implementation progress with respect to upgradation of Site.
• Check compliance of open audit & review point & submit report to coordinator and FPS compliance team.
• Implement CAPA taken on deviations/ changes controls/ market complaint.
• Identify bottle neck during planning and mitigate it.
• Ensure availability of all product document, change parts (punches & packing change parts) in time with coordination with coordinator.
• Execute tech transfer PV batch manufacturing in presence of tech transfer person to ensure for timely supply.
• Review filled documents (BMR/BPR, PV report and FG COA).
• Coordinate for Launches of New product at CMO sites with necessary information.
• Monitor and Guide the Cipla Executive & Sr. executives at CMO locations.

Quality Management System

• Procedure and evaluating the impact of change.
• To operate the Cipla Quality Management System – LMS on the Roles and Rights provided in the application.
• Ensure the compliance of any deficiencies raised by Quality Assurance during batch record review.
• To participate in the implementation and monitoring of Quality System and Quality Policy
• To ensure timely and effective communication to Senior Management. Follow up and implementation of suggestion or corrective actions suggested by Senior Management, continual improvement of the Quality System.

GMP (Good Manufacturing Practices)

• To ensure compliance with respect to supply chain management and Good Distribution Practices.
• Ensuring that all transporting vehicles meet requirement of current Good Manufacturing Practice (cGMP) and Good Manufacturing Practice (GMP) requirements of country where product is being exported by agreements.
• Responsible to ensure online entry and retention and destruction of records as per Standard Operating Procedure (SOP).
• To Monitor handling, storage, and clearance of rejected materials.

Training

• Identification of training needs and evaluation of training at LL sites as per Cipla Quality Procedures.
• Rendering FPS induction to new entrants, verifying the On Job Training Evaluation and Training.
• To operate the Learning Management System (LIMS} based on the Roles and Rights provided in the application