Bhupendra Rameshbhai Darji

C/***, Shrinath Apartment, Near Sanskar School, Saroda Road, Kalikund Area, Dholka- 382225.

982-***-****

admg19@r.postjobfree.com

Objective

To serve my expertise and experience of pharmaceutical manufacturing of sterile products by continuous learning of new technologies to achieve production goals and profits for the company with quality standards.

Academic Details

School of Science

Master of Science, 51.44%, 2005

Bhavan's R.A.Colloge of Science

B.Sc, 63.47%, 2003

M.N.C.P

Diploma in Pharmacy, 59.1%, 1999

Asarwa Vidhyalaya

GHSEB, 56.00%, 1997

Shree Kailash Vidhyalaya

GSEB, 71.57%, 1995

Work Experience

Claris Lifescience Ltd

Executive, Mar 2013 - till date

Role : Production

I) To get the monthly plan from Manager Production in the last week of every month for the next month and to check the daily plan.

II) To prepare the daily, monthly and other report for Manager - Production and to carry out the production as per schedule plan.

III) To ensure the timely information of break down to the Engineering Services and Manager- production.

Quality

I) To ensure the timely documentation of ongoing production and check the batch record on day-to- day basis.

II) To ensure implementation of SOPs for production and report if the deviation is observed to Manager production, General Manager Manufacturing and QA. III) To suggest the changes in SOPs if required.

IV) To check on daily basis, in-process control parameters of production through design documents.

V) To check and ensure the environmental norms of various production areas, to get the deviations corrected by Engineering Services department and report such deviations to Manager production, General Manager Manufacturing and QA.

VI) To check adherence of the preventive maintenance schedule. Yield

I) To check the yield at various operation points to improve the results through correct implementation of SOP and if required, recommend the changes to the Manager Production and General Manager Manufacturing.

II) To inform about yield deviation to the Manager- Manufacturing and Head Manufacturing. General Working

I) To take necessary actions on deviation, if found and report to Manager - Manufacturing. II) To continuously aware the employees for the cGMP norms. III) To implement the cGMP norms in the manufacturing areas and also during manufacturing and on continuous basis.

IV) To update ones own self on cGMP and other international standards of manufacturing. Training

I) To check the availability of trained staff and workers. II) To keep a check on trained staff and workers working in their respective position. III) To review and suggest periodic training wherever required. IV) To ensure the training of the changes in the standard operation procedure form time to time V) To continuously train the personnel working in the manufacturing area for the Current Good manufacturing practices.

VI) To ensure the productivity by training and educating the staff and workers in their respective area.

VII) Training of workers regarding clean room behavior, importance of cleaning etc. Marck Biosciences Ltd

Sr.Officer, May 2010 - Feb 2013

Role : A. Related to Clean room maintenance

B. Related to Batch Manufacturing

C. Related to Filling

D. Related to assembly

E. General Responsibility

Claris Life science Ltd

Officer, May 2006 - Apr 2010

Role : A. Related to Clean room maintenance

1. Monitoring of Temperature/Humidity/Positive Pressure of clean rooms of Line 1, Line 2, Line 3, Line 4 and if deviated from defined criteria, inform to engineering dept. 2. To ensure cleaning and disinfection of floor, ceiling, wall, pipe line, vessels and equipment as per frequency.

3. To report to Plant Manager and engineering dept. regrading to any kind of maintenance work of clean room through work request form.

4. To ensure cleanliness of sufficient numbers of garments in clean room through follow up with steriliser chemist.

5.To ensure cleanliness of air locks after worker entry and exit. 6. To ensure proper gowning of workers.

7. To ensure follow up of SOP during entry/exit from clean room 8. Training of worker regarding clean room behavior, importance of cleaning etc. 9. To ensure availability of IPA(70) bottles at the respective locations. 10.To follow clean room behaviors strictly.

B. Related to Batch Manufacturing

1.To have knowledge of each and every stage of batch manufacturing as per validation study. 2.To ensure cleaning and steaming process us carried out as per validated procedure. 3. WFI approval/batch manufacturing/Filtration/Zero sampling. 4.BPT/FFT of product filter before and after filtration. 5.WIT of air filter/nitrogen filters/vacuum filters. 6.To have knowledge regarding operation of all equipments of clean room. 7.Follow up of SOP during manufacturing of batch.

C. Related to Filling.

1. Checking LAF pressure before 30 min. of starting of operations. 2. Volume setting and volume checking at regular time interval. 3. Continuous checking of O2 content in bottle (Emulsion/Celemin/Sodium Bicarbonate). 4. To ensure proper cap sealing quality of filled bottles. 5. To ensure efficiency of worker doing visual inspection of bag. 6. To correct settings of change parts for the required fill volume. 7. To minimise the rejections.

8. To ensure entry of not more than two persons in SVP filling areas. 9. To ensure cleanliness in the clean room.

D. Related to Assembly

1. To ensure correctness of each and every minutes steps during assembling. 2. To ensure availability of assembly as per next production planning. 3. To ensure availability of assembly components as per next production planning. E. General Responsibility

1. To have through knowledge of SOP of own working area and to ensure follow up of it. 2. To ensure efficiency of worker and to achieve defined targets. 3. To maintain good relation with other colleagues of other department. 4. Manufacturing chemist is responsible for controlling rejection at different steps of production. 5. To discuss various aspects which can bring improvement or reduce rejection in the process with shift in charge and Plant Manager.

Field of Interests

Good Manufacturing & Good Documentation Practice

Skills

Certificate of Computing from IGNOU, New Delhi.

Worked on SAP system.

Worked on ERP system.

Industrial Exposure

Industrial Visit at:

Restech Pharmaceutical Ltd Nov-05 to April-06.

Inplant Training at:

cGMP & GDP

Achievements

Actively involved in good documentation in dispensing room & online entries in logbook & BMR in injectable plant company given me certificate of " You have made it" In since Sep-07. Curricular Activities

Co-Curricular

Reading & Writings

Extra-Curricular

Reading Book of News Papers..

Strength

Hard Work to Company

Hobbies

Interactin with people of multifactes

Listensing to music, Painting, Travelling

Declaration

I here by declare that the above mentioned facts are true to the best of knowledge. Date : 16/02/19

Place : Ahmedabad

(Bhupendra Rameshbhai Darji)

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