Manufacturing Operator
Resume:
Yogesh Patel
Belleville NJ 07109
Phone :973-***-**** (H)
973-***-**** (C)
Objective: To Secure a position in a pharmaceutical firm utilizing my experience and technical
Ability to positively contribute to the success of the organization.
Professional Experience
Background Summary
A technical professional with over twenty years of experience and increased responsibility
In the pharmaceutical industry. Achieved good experience in the manufacturing,
Development of the standards and procedures, technology, validation of new processes
And in the qualification of equipments and utility systems.
AUROLIFE PHARMA (AUROBINDO PHARMACEUTICAL COMPANY)
MARCH 2016 TO PRESENT: Manufacturing operator granulation and blending
Ensure that all solid dosage products are manufactured within
cGMP and SOP guidelines
Responsibilities includes operation and set up of various
Equipments like different sizes of V blenders,Gemcomatic
Blenders,Alliance fluifbeddryers,Niro fluidbed dryers,TK
Fielder high shear mixers, Fitz mills Swecco sifters.
OHM LABORATORIES( A SUN PHARMA COMPANY)
JANUARY 2011 TO MARCH 2016: Manufacturing Operator Granulation and Blending
Ensure that all solid dosage products are manufactured
within CGMP and SOP guidelines
Experience in the setup and operation of the following
High Shear Mixers Mechanical Sifters Fitzpatrick Mills
PK V Blenders CDM Blenders Fluid Bed Dryers
Glatt GPCG Mega view 120
PLIVA INC.,
17 West Street
East Hanover, NJ 07109
March 1993 to Dec 2008: Supervisor level I/ Operator level II Granulation - & Blending Dept.
Responsible for managing and maintaining daily shift operations as per
The established schedule
Responsible for handling, documenting and photocopying any/all
Temperature/humidity charts/graphs as specified in the manufacturing
Batch record.
Accurately document and review master batch record and associated
Paperwork to insure use of proper material and equipments
Maintains the equipment cleaning and use logs for all rooms/equipments
Interfaces with designated personnel of other manufacturing areas in
Order to insure the proper flow of the operations for the entire
Manufacturing process.
Strong leadership and interpersonal skills, with the ability to teach
And coach individuals from diverse backgrounds with varying
Communication and technical skills.
Maintains current training records for required procedures and training
Assignments.
Insure that all the manufacturing of solid dosage is within the cGMP’s
And S.O.P guidelines.
Assist Sr. supervisor in performing any product/process investigation
Relative to the granulation/blending operations.
.
Experience in the setup and operation of the following equipments
AMF Glen Mixer Fluid Bed Dryer PKV-Blender
Nica Granulator Tray Dryer Ribbon Blender
Hobart Mixer Lydon Oven Gemcomatic Blender
Fitzpatrick Chilsonator Oscillator Fitzpatrickmill
Accelacoat48”coating pan Accelacota48” (Compucoater)
Quality Assurance Department: Group Leader
Responsible for the direct scheduling of the second and third shift
Personnel.
Perform In-process testing on finished granulations/products insuring
That the products meet the specifications.
Responsible for conducting any relevant product/process investigation.
Ensure continuous improvement of the quality system. Propose process
Improvement to strengthen system (Both quality and Manufacturing).
Develop operational, training and cleaning Sop’s related to the
Manufacturing operations.
Conducting GMP audits of the manufacturing facilities and operations.
Inspect products during production run to ensure compliance to quality.
Perform batch record review after each manufacturing stage and also
Responsible for in-house label reconciliation.
Provide approvals to equipments for cleanliness and condition prior
To use.
Motivate, guide and oversee facility personnel to ensure that the quality
And process systems are being fulfilled.
Interact with R&D/validation/qc dept. with existing and new products
And process issues.
Provide training to various personnel to ensure quality systems are being
Executed properly and consistently meeting Sop/Gmp/Regulatory
Requirements.
Perform all duties while following all strict standard operating
Procedures and all good manufacturing practices as required by the
Company and FDA.
Education: BS (Bachelor of Science)
University of jodhpur
Jodhpur, Rajasthan
India
EMAIL:******@*******.***
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