Division
Department
Sub Department 1
Job Purpose
Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and manufacturing targets in time
Key Accountabilities (1/6)
Monitor and control planned production by daily activity review as per production plan to meet production targets and quality standards
Review planned production v/s 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
Key Accountabilities (2/6)
Ensure maintenance is carried out as per standards to realise optimum utilisation of manufacturing consumables
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
Key Accountabilities (3/6)
Prepare, review and update GMP documents to meet regulatory compliance and quality of product
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
Review new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendations
Key Accountabilities (4/6)
Ensure adequate and trained manpower availability across shifts to ensure production continuity




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
Key Accountabilities (5/6)
Monitor employee and workplace safety to maintain safe environment
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
Key Accountabilities (6/6)
Implement Jaagruti initiatives and manufacturing excellence practises for continuous improvement
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
Major Challenges
Meeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning
Keeping up with production schedule during facility renovation and equipment upgrade
Utilisation of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plans
More lead time for approval of regulatory documents by internal and external stakeholder Overcome by regular follow ups
Unavailability of machine spares items because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare to be maintain all the time at stores for all identified machine.
Long cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stake holder i.e. RA, R&D;, LCM team and CQA, which can be overcome by defining the timelines for each stakeholder
Issues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplier
Key Interactions (1/2)
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 recent products (Project Basis)
Stores and Warehouse
for RM/PM related activities (Daily)
HSE
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)
Key Interactions (2/2)
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)
Dimensions (1/2)
Direct Reports : 40
Team Size : 70
Tech transfer batches executed – Average 5-6 batches per month
No. of commercial batches executed - ******* batches/Month
Number of dosage forms handled : 2
Capacity of delivering 180 million/month volume
Achieve internal OTIF more than 90%
YOY improvement in shift operations efficiency
Achieve Zero reportable accidents / incidences during manufacturing
Achieve set target for batch failure reduction
Achieve 0% errors in online documentation
Meet 100% compliance to SOP and safety regulations
Dimensions (2/2)
Key Decisions (1/2)
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
Key Decisions (2/2)
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
Education Qualification
Graduate in Pharmacy
is preferable
Relevant Work Experience
7-9 years of experience in Formulation Manufacturing with understanding of manufacturing procedures, cGMP and systems
and related documentation

📌 Section Head - Production (India)
🏢 Cipla
📍 India