Assistant Manager

Ajay Patel

***-** ******* **** ****,

Mississauga, ON, L5B 1C9

Phone (Home) - 905-***-****

(Office) – 905-***-**** Ext 4085

*************@*****.***

Career objective: To develop my personal and professional career as Production Supervisor in a progressive organization with stimulating and challenging work environment where I can utilize my potential and skill in conjunction with expanding my expertise

Profile:

•More than 20 years of work experience in pharmaceutical indutries

•Excellent knowledge of fermentation, documentation and microbiological testing

activities in Pharmaceutic manufacturing

In-depth knowledge of GMP,GLP,FDA, SOPs, ISO quality management system and internal and external audits

•Team leader, team player, dedicated , result oriented professional, proactive, multitasking, excellent interpersonal and organizational skills

•Instrumental skills include Microscopy, Culture development on different media, Autoclave, HPLC, pH meter, Viscometer, Bio-reactors, Batch controllers & scanners

•Excellent computer knowledge of Microsoft Office, Internet and familiar with SAP system

Professional background:

11/11 – Cont’d Laboratory Assistant Maxxam Analytics - Canada

• Preparation of different Microbiological media

• Media autoclave and masterclave

• Calibration of different instruments like pH meter, balance etc.

• Maintain supply of lab chemicals, glassware’s and other requirements

• Cleaning and sanitation of glassware

• Management of Bio-hazardous waste and its disposal

06/11 - 11/11 Production Packager Ciba Vision - Canada

• Packaging different Ophthalmic products as per SOD and GMP

• Operated Scandia and Langen packing machine

• Operated Lumonic and Khrone labeling machine

• Trouble shooting of machine during production

• Documentation as per GDP and GMP

• Managed product change over as per GMP

• Properly managed rejects as per GMP

• Cleaned and sanitized all production machines & equipment’s as per SOP and GMP

10/10 - 05/11 Packager Kik custom products - Canada

• Packing different Cosmetic products as per GMP

• Operated bottle filling machine

• Operated tube filling machine

• Operated cartoner and packing machine

• Documentation as per GMP

Ajay Patel Page-2

2008 - 2010 Supervisor ( Assistant Manager - Fermentation ) Alembic Ltd.- India

• Prepared monthly production plan to meet the production target

• Planned daily activities for shop floor

• Aseptically inoculated Germinator, Seed and Production reactors

• Studied impact of different raw materials on growth & production. Rationalized raw materials and their use to optimize the production

• Analyzed data in terms of batch tracking to monitor specific productivity rate and its impact on total variable cost so that every batch can be terminated at minimum cost to make product cost efficient using batch cut-off tool

• Continuous tracked all batches of production at all steps

• Conducted pilot experiments to study technology up gradation

• Prepared production graphs and studied trend of production

• Studied impact of different cultural condition on growth & production

• Studied different phases of growth of Bacteria and Fungi

• Prepared batch summery report for every batch

• Prepared SOP of different products and processes and implemented

• Successfully supported ISO 9001 & 14000 and well conversed in facing audits

• Coordinated with other departments for production requirements

• Planned shutdown of plant for maintenance

• Provided guidance to team and setting up clear goals and expectations

• Carried out yearly performance assessment of every staff

• Train new employees.

2003 - 2008 Sr. Microbiologist ( Sr. Executive - Fermentation ) Alembic Ltd.- India

• Production planning and distribution of work among workmen

• Preparation of different media for different stages of growth and production, adjusting volume and pH, Sterilization of different media and feed solution and cooling to required temperature

• Cultivation of Bacteria and Fungi in different media under aseptic condition

• Aseptic inoculation of Germination, Seed and Production reactors and maintaining required cultural conditions for growth and production like Temperature, Aeration, Agitation, pH, Nutrient Concentration, and changing it as per requirement of production

• Study of impact of different cultural condition on growth & production

• Aseptic collection of sterility samples, inoculation of sterility media with samples and incubation at different temperatures for bacterial, fungal and yeast growth and daily microscopic observation of any growth and color change of media and identification of contaminants

• Antibiotic sensitivity testing for contaminating bacteria

• Testing potency of products by HPLC and Bioassay methods

• Study of different phases of growth of Bacteria and Fungi

• Preparation of shift report

• To follow SOP of production

• Coordinate with other departments for production requirements

• Train new employees

1996 - 2003 Jr. Microbiologist ( Jr. Executive ) Alembic Ltd.- India

• Production planning and distribution of work among workmen

• Preparation of different media for different stages of growth and production, adjusting volume and pH, Sterilization of different media and feed solution and cooling to required temperature

• Cultivation of Bacteria and Fungi in different media under aseptic condition

• Aseptic inoculation of Germination, Seed and Production reactors and maintaining required cultural conditions for growth and production like Temperature, Aeration, Agitation, pH, Nutrient Concentration, and changing it as per requirement of production

• Study of impact of different cultural condition on growth & production

• Aseptic collection of sterility samples, inoculation of sterility media with samples and incubation at different temperatures for bacterial, fungal and yeast growth and daily microscopic observation of any growth and color change of media and identification of contaminants

• Antibiotic sensitivity testing for contaminating bacteria

• Testing potency of products by HPLC and Bioassay methods

• Study of different phases of growth of Bacteria and Fungi

• To follow SOP of production and instruction of Sr. Microbiologist

1988 - 1996 Shift Microbiological Assistant Alembic Ltd.- India

• Preparation of different media for different stages of growth and production, adjusting volume and pH, Sterilization of different media and feed solution and cooling to required temperature

• Cultivation of Bacteria and Fungi in different media under aseptic condition

• Aseptic inoculation of Germination, Seed tank

• Aseptic collection of sterility samples, inoculation of sterility media

• To follow of SOP of production

ACHIEVEMENTS

• Reduced contamination level from 20% to less than 5%

• Work load analysis to save analytical resources

• Quality of products improved by manipulating process parameters and feed patterns

• Reduced production cost by implementing recovery of PAA from fermented broth

• Actively participated implementation of new technologies to meet improved cGMP requirements.

• Optimized seed transfer technique by using exit gas analysis

• Implementation of cost-effective alternate material sources

EDUCATION

• Master of Science (Microbiology) from Nagpur University 2005

• Diploma in Applied Microbiology from S.P.University 1988

• Certificate in Medical Lab. Technology form MahaGujarat Hospital 1987

• Bachelor of Science (Microbiology) from Gujarat University 1986

TRAINING

• Current Good Manufacturing Practice ( Ciba Vision – Canada )

• Good Documentation Practice ( Ciba Vision – Canada )

• First Aid

• Fire fighting

• Health and Safety

• Safe Lab Procedures

• Spill response team member

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