1. CURRICULUM - VITAE
KUNJAL.K PATEL + 91 9974577140
29, Radhe -2 bungalows, kunjpatel812@yahoo.com
Nr. Raj Chandra tenements, kathwada road,
Naroda-382330. Ahmedabad.
JOB OBJECTIVE
A career in the industrial sector with a reputed organization upholding professional values to
enhance mutual growth, working at full efficiency and to hold responsible and challenging
position.
CAREER PROFILE
Having 8 years experience in Small volume Injectables in Lyophilization plant.
EDUCATIONAL QUALIFICATION
Course University / Board College / School Year of
Passing
Percentage
M.S.c
Microbiology
University of Mysore M.N.Virani Science
College
2009 67.00%
B.S.c
Microbiology
Sardar Patel
University(V.V.Nagar)
V.P.& R.P.T.P
Science College
2007 58.00%
H.S.C. GSEB – Gandhinagar E.M.S.
School(Bhadran)
2004 45.00%
S.S.C. GSEB – Gandhinagar E.M.S.
School(Bhadran)
2002 70.00%
PROFESSIONAL EXPERIENCE
1) Cadila Healthcare Ltd. (Zydus Group) Vatva,Ahmedabad
Position : Production Officer-1
Date joined : Sept- 2012 to till date
Job responsibilities:
I have successfully completed project of two new line qualification for lyophilized
products up to media fill completion at Zydus Cadila.
Also gone for F.A.T. of
2. LSI LYOPHILIZER
MACHINE FABRIC STEAM STERILIZER
N.K.PHARMA CAPPING MACHINE
Monitoring & Analysis of Production activities with quality and quantity as per SOP.
To do weekly and monthly planning of production schedules and accordingly that
dispense all the Raw materials used in Batch manufacturing process.
To co-ordinate and follow up with Planning and warehouse for timely dispensing of
material, availability of material and receipt of finished goods.
Batch Preparation of Parenteral Products.
To handle cleaning in place & steaming in place of Manufacturing vessels or tanks &
lines.
To provide the job training and guidance to the trainee chemists, operators and workers
for proper gowning & works handle into the classified areas.
To allocate the work among operators on a daily basis on machines/work center / shifts
and prepares shift schedules.
To supervise the production activities on a day-to-day basis guiding the operators and
trouble shooting for smooth operation of machines/processes.
Testing of Filter Integrity by BPT instrument and maintain their records.
To validate the area by online particle countered machine and then starting of the filling
process.
To handle Autoclave for sterilization of filled Ampoules and Vials as per the SOP
guidelines.
Revision of Batch Manufacturing record and other related documents for its completion
of various intermediate and final stages.
To prepare documentation like Batch Manufacturing Records, protocols, SOP (Standard
Operating Procedure) etc related to Production areas in aspects of operation, cleaning,
utility, maintenance.
To handle Process Validation, Area Validation, instruments calibration or validation.
To handle corrective and preventive maintenance of various instruments and machines
and from that maintain corrective and preventive maintenance record.
Co-ordinate and follow up with engineering dept for timely availability of the services to
attend breakdowns, interruptions and scheduling of maintenance.
To initiate Change Control procedure, incident handling, planned deviation as required
under the relevant SOP.
Experience to face audit and audit preparation. { WHO GMP, USFDA, MCC }
Exposure to preparation and review of SOP of production related activities.
3. Experience of new line installation with area qualification and all equipment
qualification.
Exposure to IQ, OQ, and PQ of different equipments like Autoclave, Vial Washing
Machine, Vial Depyrogenation Tunnel, Vial Filling Machine, Vial Sealing Machine and
Lyophilizer.
2) SUN PHARMACEUTICALS Ltd. Halol,Baroda
Position : Production Officer-2 ( Lyo & Clean area )
Date joined : August 2009. Date left: September 2012
Job responsibilities:
Batch Manufacturing of Parenteral products.
To handle cleaning in place & steaming in place of Manufacturing vessels or tanks &
lines.
To supervise the production activities on a day-to-day basis guiding the operators and
trouble shooting for smooth operation of machines/processes.
Exposure of Operating & Validation equipments like Vial filling machine, Vial washing
machine, Vial sealing machine, autoclave and lyophilizer.
Exposure to preparation and review of SOP of production related activities.
To co-ordinate and follow up with Planning and warehouse for timely dispensing of
material, availability of material and receipt of finished goods
Ensure training of SOPs to Workers, Operators.
Issuance of BMR from QA ,coordination with QA/QC regularly in process /intermediate
/Bulk sampling and any system related work with Validation and Calibration of
Equipment.
Verification of dispensed raw material, primary packing material and secondary packing
material as per production plan.
Exposure to Glass vial, plastic bottles and Glass Ampoule for Parenteral preparations.
To prepare and verify the status labels, product labels during every stage of batch.
Exposure to Lyophilized products.
Experience to face audit and audit preparation. { WHO GMP, USFDA, TGA, MHRA,
ANVISA }
Exposures to periodic media fill activity.
Exposure to IQ, OQ, and PQ of different equipments like Autoclave, Vial Washing
Machine, Vial Depyrogenation Tunnel, Vial Filling Machine, Vial Sealing Machine and
Lyophilizer.
4. 3) LYKA LABS Ltd. Ankleshwar, WHO GMP certified company
Position : Jr. Production Executive
Date joined : December-2007 Date left: August -2009
Job responsibilities:
Areas to be handle:
Washing area
Manufacturing area
Aseptic filling area
Lyophilizer (manual operation)
To supervise the production activities on a day-to-day basis guiding the operators and
trouble shooting for smooth operation of machines/processes.
To allocate the work among operators on a daily basis on machines/work center / shifts
and prepares shift schedule
Experience to face audit and audit preparation. { WHO GMP }
Batch Manufacturing of Parenteral products.
Exposure to Lyophilized products.
Verification of dispensed raw material, primary packing material and secondary packing
material as per production plan.
Ensure training of SOPs to Workers, Operators.
Exposures to periodic media fill activity.
TECHNICAL EXPERTISE
Vial washing Machine (2ml,5ml,10ml,20ml,100ml) {GRONINGER,N.K.PHARMA,
PETALS}
Ampoule washing machine (5ml,10ml,20ml){KEMBERT}
Depyrogenation Tunnel {KLENZAIDS,PETALS,GRONINGER}
Filling Machine {ROMACO-ITALY, TURKING -CHINA}
Dry Heat sterilizer.
Moist Heat sterilizer.
Sealing machine. (2ml, 5ml, 10ml, 20ml)
N.K.Pharma S.I.P. Unit.
Image Ink jet Printer.
Palltronic & Sartorius filter integrity testing Machine.
5. AUDIT PARTICIPATED
USFDA, MHRA, MCA, TGA, MCC & Customer Audits.
COMPUTER SKILL
Conversant with Word and Excel, internet operating knowledge.
PERSONAL PROFILE
Date of birth : 8th December 1984.
Marital status : Married.
Proficiency in languages : English, Gujarati, Hindi.
Hobbies : Scientific Reading, Volleyball, Physical Exercise.
Strength : Zeal to learn, hard work, stability
REFERENCES
1.) Mr. ANISH PATEL 2) Mr.DEVESH SHARMA
Assistant manager, Executive,
Sun Pharmaceuticals Ltd., Halol Cadila Health Care. Ltd
Mob. +91 968704345 Mob +91 9586686122