Accountability Cluster

Major Activities / Tasks

• Review planned production vs. actual production daily and control the production activity of the plant as per the schedule

• Prepare production schedules for the block and ensure adherence to the schedules

• Ensure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts

• Ensure execution of new product & product transfer by performing gap analysis to meet market requirements

• Review in-process analysis on daily basis to enhance the quality of final product

• Monitor unit operations and processes to avoid failures

• Ensure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue

• Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering

• Optimise the utilisation of manufacturing consumables as per the budgets to reduce overhead cost

• Conduct the daily cross functional AET meeting to continuously improve Yield, Solvent recovery, reduce OOS, OOT and complaints.

• Evaluate the requirement and ensure the availability of critical spare and consumables for the machines to avoid time loss during any machine breakdown

• Prepare the facility and rectify issues related to facility management and documentation for audit readiness

• Handle investigations, OOS, OOT, change controls, deviation & CAPA in the block

• Ensure online documentation for any non-conformance to meet GMP by performing surprise checks

• Prepare and review the qualification, validation and other documents to maintain GMP

• Participate in the internal and external audits to assure system control

• Ensure effective utilisation of manpower in each shift by understanding workload and requirement to get desired production output

• Plan and impart training on SOPs, new guidelines and policies to for achieve zero non-conformance

• Ensure all operations are performed as per safety norms to avoid accidents in plant

• Ensure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule

• Conduct safety training by coordinating with HSE to promote a culture of safe working

• Ensure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogue

• Review the OOE data and monitor the PDCA system to minimize the losses

• Track monthly change over time of machine to sustain the baseline

• Prepare the plans for utilization of bottleneck machines to reduce the time loss

• Monitor the yield of runner products to ensure yield above baseline

Internal

External

• Quality Assurance/Control for scheduling of batches, issues in product (Daily)

• Engineering & Utility for system related queries (Daily)

• Technical Support for troubleshooting in products (Case Basis)

• Technology Transfer for support in new products (Project Basis)

• Stores and Warehouse for RM/PM related activities (Daily)

• EHS for safety rounds and PPEs (Daily)

• Capacity panning, R&D, RA other manufacturing unit for Multiple formula harmonization and batch size optimization (Case basis).

• QA and CQA for preparation and implementation of SOP’S (Case Basis)

• IT for computerised system validation (Case Basis)

• Central SCADA Team for Real time process data-Acquisition and control (RTPD-AC) project way forward. (Fortnightly)

• Original equipment manufacturers for any operation related queries and for machine spare related queries (Monthly).

• External Auditors during facility audits (as per schedule)

• Equipment tooling suppliers for any tool related queries and updating the performance of the tools (Case Basis).

• Maintenance contractor for Instrument calibration scheduling and its execution (Monthly).

• Civil contractor for civil work (Case Basis)

Decisions

Recommendations

• Scheduling of production batch

• Utilisation of manufacturing consumables

• In-process checks

• Manpower scheduling shift wise as per production plan and authorization of the leaves accordingly

• Production Plan forecast (To Plant Head)

• OOS, OOT, Complaint Investigation (To Plant Head)

• Deviation and implementation of CAPAs (To Plant Head)

• Modification in plant and equipment (To Plant Head and Engineering Team)

• Identify the products where we can increase the batch size in existing resources to enhance the plant capacity to Plant Head

• Development of cost-effective alternate vendors for tools and equipment accessories to Plant Head

• Modification in qualification document to Plant Head