Devendra Brahmbhatt

Tel;689-***-**** Email; ad2ag1@r.postjobfree.com

Orlando, FL 32836

Skills

Fluorescence assay, Continuous improvement, Packaging, Good Manufacturing Practices, Root Cause Analysis, Materials Management, Quality Assurance, Scheduling, Staff Supervision, Training and Development, Instruments Trouble shooting, Corrective and preventive action (CAPA), Team Management, Assay Development, Batch Manufacturing Record BMR, Biochemical assay, Colorimeter assay, ERP Systems, In vitro assay. Validation Analytical DQ IQ OQ. PQ

Inventory Management, Lab Management, Lab Operation, Laboratory Information Management system (LIMS), Method validation, Procurement Logistics, Quality Assurance, Quality control, Quality Inspection, Quality

Management, SOP Development, stability assay, Supply Chain, Vendor Management, Strategic planning for raw material purchase, Production Planning. Productivity Improvement. Analytic Problem Solving. Lean manufacturing Six sigma. Packaging finished products.

Quality inspection, Resource planning, Team Management, Pharmaceuticals manufacturing.

Inspection, Cleaning Validation, Quantity Surveying, Measurements. Process Validation, Analytical Validation.

Instruments: spectrophotometer, Fluor photometer, HPLC, TLC. Polari meter, FTIR. Viscometer, potentiometer, Refractometer

LIMS, qualifications. Digiqual qualification.

Sterilizations cycle’s Parameters Development and challenge test on sterilization.

Dry heat sterilization, Developing new parameters on dry heat sterilization., Validation of dry heat sterilizati

Dissolution tablets and capsules.

TOC of water.

Languages:

English Fluent

Certifications:

Q C certificates from BEGECA Germany

Quality control and process validation, Present

Education

Graduate in Chemistry, M.B. Patel science college, S. P. UNIVERSITY - Anand, Gujarat May 1975 - Jun 1980

IATF 16949:2016

Technical Support

Manufacturing - 10+ years

Plant Management - 10+ years

** Documentation, production.

Quality Control - 10+ years

Production Planning 10+ years

Quality Assurance - 10+ years

Lean Manufacturing - 8 years

Production Management - 10+ years

CGMP - 10+ years

Work Experience

Seqens Pharma Solutions. Newbury Port, MA Feb 2023-Sep 2023

QC supervisor

The Company is engaged in Manufacturing APIs I Currently am in USA, working with Seqens as a QC Supervisor in Massachusetts. I am accountable for quality control function of the company.

My duties involve: -cGMP is practiced in process and documentation. Data review

Direction and control of the entire quality control system and production functions of the company.

Management of overall strategic planning and supervision

implementation of GMP and maintenance of quality of raw materials and packaging materials.

Overseeing daily operation of quality controls and production.

Conducting research and developing new products.

Designing preventative maintenance and machine servicing schedules.

Managing the general administration of staff relations

Process validation and Analytical validation in place

Sampling, analysis, and release process Followed-Supervision /review of analytical reports -routine analysis of finished products samples and in process samples

Performing Stability tests on all products produced in company.

Implementing CGMP.

Validation of analytical methods and production processes.

Ensure that standards and safety regulation observed., Document quality assurance activities and create audit report.

Make recommendation for improvement in documentation. And routine inspections

Reviewing BMR and QC Reports.

Practicing GLP

Working in a team for an analyst of API by using HPLC(Agilent) for assays, UPLC, FTIR -Analyzing raw materials and finished products

Documentation on Deviation, CAPA, Change control, root cause analysis, Customers complain.,

Validating of analytical methods and process validation. Documenting OOS and OOT Trouble shooting HPLC UPLC.FTIR

Valencia Cosmetics LTD – Nairobi, Kenya May 2018 - Jan 2023

General Manager/Operations Manager

The company is engaged in manufacturing body care, skincare and hair care products.

My duties involved:

Managing production and production Planning-Quality control.

Plant maintenance

Raw materials procurement, and leading sales and marketing team.

Strategic planning, setting up targets for sales and production team.

I Initiated and developed hair care products such as hair spray which takes care of growth of hair and also works as an anti-dandruff. This product gained popularity and grew sales revenue. I developed hair binding/styling gel which was well accepted by consumers. The production of this product grew to the extent of 35 % of the total production.

Management of treatment of water by deionization, reverse osmosis and micro filtration since water is an important raw material in our formulation

Dawa pharmaceuticals ltd Nairobi, Kenya Oct 2006 - Apr 2018

Production Manager

The company was engaged in production of oral, topical, sterile and injectable dosage forms.

My duties involved:

Managing production: planning and execution to meet the production targets.

Raw materials and packaging materials procurement

In process control, administrative control

Implementing CGMP

DQ IQ OQ PQ

Participating in Analytical Validation.

Validation of production process.

Scheduling Production machines maintenance. and approving SOP.

Monitoring vials, ampules and change parts sterilization, Aseptic processing

Documentation of production

Initiating release procedure of the products.

Final overview BMR (Batch Manufacturing Record).

Validation and quantification through HPLC of Simadzu make

Running the plant efficiently. We were never out of stock.

Planning of production was on time so company gained sales.

I started with them doing 5million ksh in sales. When I left, the company was doing 156million in sales per month.

Kenya sterile supplies Ltd (KSSL), Kenya Apr 2004 - Apr 2006

Plant Manager

The company is engaged in manufacturing large volume I.V. parenteral

I was the technical and administrative head of this plant, monitored all functions

My duties Involved:

Compounding, filling and sterilization

Overall operation of production

Quality control

Overseeing raw materials and packaging materials procurement

Implementing aseptic technique.

Approving SOPs for operation and maintenance of the plant.

Monitoring sterility testing

Monitoring Pyrogen testing and certifying documents for final product release.

Monitoring water treatment for sterile water by reverse osmosis and micro filtration.

Managing general administration and Implementing CGMP.

Monitoring air handler unit for sterile air flow in aseptic areas.

Monitoring stringent implementation standards and SOP. of Vial washing and Ampoule washing Rubber bung washing and sterilization. Aseptic Processing .

I developed a new product “Ringer Lactate large volume parenteral 500 ml” and “Metronidazole IV fluid 100ml”. confirmed stability and effectiveness.

Ultra-food chem. Ltd Nairobi, Aug 1997 - May 2003

Director Quality Assurance/Production

The company engaged in manufacture and distribution of nutraceuticals, soft drinks, drinking water, (water treatment by UV, Microfiltration and reverse osmosis) cosmetics and disinfectants

My duties involved:

Direction and control of the entire quality control system and production functions of the company.

Management of overall strategic planning and supervision

implementation of GMP and maintenance of quality of raw materials and packaging materials.

Overseeing daily operation of quality controls and production.

Conducting research and developing new products.

Designing preventative maintenance and machine servicing schedules.

Managing the general administration of staff relations

The entire plant was my initiation. I developed soft drinks- aerated and non-aerated of 10 flavors. I also developed domestic cleansers which made company to gain remarkable revenue.

Pharmaceutical Products Ltd Nairobi, Kenya Jul 1992 - May 1997

Plant Manager

The company was engaged in manufacturing pharmaceutical products, non-sterile, Oral and topical pharmaceutical dosage forms.

My duties Involved:

Managing routine activities of production planning and execution,

Providing assistance to all quality control functions

Inspecting all incoming raw materials and outgoing finished products

Monitoring internal receipt and dispatches of materials.

Managing all marketing functions of pharmaceutical products.

Setting the targets of production and sales team.

Implementing cGMP.

Company was doing 2 to 3 million KSH in sales. I strategized the production, so sales increased. The facility was not capable of sustaining production due to the high demand, so we had to buy land and initiate a bigger plant.

Laboratory and Allied Ltd, Nairobi, Kenya Dec 1990 - June 1992

Production chemist/Production Manager Sterile injections

The company was involved in manufacturing sterile, oral and topical products.

My duties Involved:

Managing production planning, raw material procuring for the sterile injectable dosage.

Monitoring quality control and production process.

Supervising, packaging and dispatching of finished goods

Certifying finished products, complying with standards and Implementing CGMP

Monitoring sterilization processes of products and aseptic techniques for operation.

Monitoring air handler unit assuring sterile air flow in aseptic areas.

Monitoring implementation of stringent SOP, of vials, ampules washing and sterilizing.

Periodically performing challenge test on sterility.

On commissioning the plant, I lodged small volume parenteral products for the registration. We were given initial permission to produce powder /antibiotics injections and then I started liquid injectable.

Regal pharmaceuticals ltd, Nairobi, Kenya Nov 1988 – Oct 1990

Quality control chemist/Manager

The company was engaged manufacturing Injectable products and oral pharmaceuticals.

My duties Involved:

Analyzing various raw materials, finished products and in process control samples.

Directing quality control function of company, which involves sterility test and pyrogen tests

Monitoring Stability tests on all products produced in company.

Implementing CGMP and validation of analytical methods and production processes, by use of methods developed in house and by USP, BP and IP stated methods.

Using physicochemical method, HPLC, LC, TLC IR FTIR methods

I developed methods of analysis of multi-ingredients liquid orals

Elyes chemical Industries Ltd Nairobi, Sep 1983 to Oct 1988

Quality Control Chemist/ Manager

The Company was engaged in manufacturing oral / topical pharmaceutical formulations.

My duties Involved:

Maintaining of quality standards for various products such as tablets, capsules, oral dry syrups, liquid orals, ointments and creams.

Controlling and planning production right from selecting raw materials up to final finished products

Analyzing raw materials and finished products

Implementing CGMP

Validating of analytical methods.

We had to use physico chemical methods, UV, HPLC, LC, TLC IR FTIR and other instruments.

I developed Benzoyl metronidazole suspension and confirmed stability and effectiveness.

Alembic Pharmaceuticals Ltd - Vadodara, Gujarat Aug 1980 - Mar 1983

Research Chemist

The company was involved in manufacturing antibiotics from basic stage, liquid injectable and oral pharmaceutical formulations. The company is largest of its kind in India. I worked under quality assurance director.

My duties involved:

Distributing work to junior chemists, training them in analytical work,

Sampling and analyzing, of various antibiotics like Ampicillin, Amoxicillin, Cephalexin, Rifampicin, Streptomycin, Kanamycin, Tetracycline, Erythromycin, Chloramphenicol etc. by using methods stated in USP BP IP and our own developed methods.

Certifying final bulk product and process control.

Monitoring validation of production process and Physicochemical analytical methods, HPLC, LC, TLC. IR FTIR,

Approving SOP of each function in production.

I developed production process by using sugarcane juice instead of sugar in fermentation process of penicillin manufacturing. It proved to be cost effective and potency remained the same. This was done on a pilot scale.

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