Devendra Brahmbhatt
Tel;689-***-**** Email; ad4037@r.postjobfree.com
Orlando, FL 32836
Skills
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 sterilization
Dissolution tablets and capsules.
Vendor qualification supplies facility, documentation, processing, QC/Inspection.
Contract manufacturing, pharmaceutical dosage forms and APIs
Production of sterile dosage forms Small volume and large volume .IM and IV
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
External QA inspection on vendors/suppliers manufacturing site 10+years
Aseptic tech Injectable IV and IM.10+years
Contract manufacturing (CDMOs) of pharmaceutical dosage forms and APIs 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.