D for Oncology Manager
1.
Have
sound
knowledge
of
Documentation
viz.,Master
BMR,MMF,
Technology
transfer
documents,
Validation report, Analytical method transfer, formula, equipment comparison, regulatory requirement,
Gap Analysis, Batch Manufacturing Records, validation/qualifications protocols and Standard operating
procedures.
2.
Participated in new product launches and process validation protocol & Report.
3.
Coordinating
with
Research
and
Development
Division,
Regulatory
Affairs,
Analytical
Department,
Supply
chain
for
material
procurement,
Quality
Department
Regulatory
Affairs
for
smooth
product
transfer.
4.
Proficient in c-GMP requirements, Documentation requirement, process and dosage form requirements
5.
Preparation in
Equipment Qualification like Design Qualification, Installation Qualification, Operation &
Performance Qualification,
6.
Knowledge of pharmaceutical manufacturing Equipments, international requirements, pharmaceutical
plant design.
7.
Have successfully qualified new manufacturing facilities and equipment
8.
Responsible for handling of Oncology products Manufacturing and packing.
9.
Responsible for safety, quality and delivery for manufacturing area.
10.
Excellent experience in managing production, planning and execution of operation.
11.
Responsible for ensuring compliance to the current regulatory requirements, quality standards &
continuous improvement in quality.
12.
Review the available resources, production requirements & forecasts of a block as per production
plan and monitor its implementation.
13.
Identify the bottlenecks in the course of production in a block and mitigate the same
14.
Ensure the facility upkeep and rectify issues related to facility management and documentation
for All time audit readiness. (24X7).
15.
Methodical
analysis
of
Monthly
data
review
related
to
yield
improvement
and
OEE
improvement and time saving in operation and cleaning.
16.
Review the reject analysis and target the elimination of variables in the process resulting in yield &
efficiency improvement.
17.
Drive continuous improvements and ensure reduction in process cycle time through operational
studies to reduce production cost and make the capacity available without CAPEX.
18.
Conduct operational study to find improvement areas and implement new development projects
19.
Responsible for process automation, process optimization and process control.
20.
Mentor and coach the teams by imparting the training at all level to avoid operating error, adhering to
GMP practices in-process failure and energy saving
21.
Active involvement for the preparation of SOPs for handling of batch reports generated by machines
involved in manufacturing and packing.
22.
Preparation of monthly plan and achieving monthly production target through successful weekly
execution and 100% achievement of C vs A.
23.
Addressing Market complaints with solution, handling change control and deviation related to a
positive change or incident.
24.
Provide training to team about machine assembling and techniques of yield improvement. Guide
them for their growth and skill up gradation so that they can be a valuable part of organization.
25.
An effective communicator with excellent relationship building & interpersonal skills, problem
solving attitude, possess a flexible & detail organizational abilities.
26.
Effective resource planning for optimizing man and machine utilization, reducing wastes to enhance
productivity.
