Quality Control Assurance

Devendrakumar Brahmbhatt

E: ************@***.*** M: 689-***-****

Green card Holder, Ready to relocate

Summary

Passionate and motivated Quality Control Specialist with 15+ years of experience in managing quality control procedures, lab operations, including inventory management, batch record review, ensuring availability of resources. Skilled in developing protocols for specialized equipment, including Filler equipment, and Genesis Capper, managing data organization and analysis with MS Office Suite. Experienced in optimizing production processes and identifying inefficiencies, implementing corrective actions, aseptic gowning and ensuring GMP compliance. Proficient in addressing process issues through root cause analysis, overseeing Change Control processes, and conducting PFMEA for risk assessment to ensure seamless production and compliance with Standard Operating Procedures.

Skills:

Continuous improvement, Packaging, Good Manufacturing Practices, Root Cause Analysis, Materials Management, Quality Assurance, Scheduling, Staff Supervision, Training and Development, Instruments Trouble shooting, Deviations, Investigation, Root cause analysis, Corrective and preventive action (CAPA), Team Management, Assay Development, Batch Manufacturing Record BMR, Biochemical assay, Colorimeter assay, ERP Systems, In vitro assay. Instruments qualification, 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.

SOP Development, stability assay, Analytic Problem Solving.

Supply Chain, Vendor Management, Strategic planning for raw material purchase, Production Planning. Productivity Improvement. Lean manufacturing Six sigma. Packaging finished products.

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

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

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

Manufacturing Sterile dosage forms, LVP and SVP (large and small volume parenteral)

Batch Manufacturing Record review and reconciliation On IPQC (in process Quality control)

New product development. (NPD) New product introduction. New product launch.

Customer complaints, Investigation.

Manufacturing Liquid orals, Tablets, Capsules, Ointments Creams and veterinary products.

LIMS qualifications. Digiqual qualifications, and Office dynamics

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, Batch manufacturing record. documentation, processing, QC Inspection.

Contract manufacturing, pharmaceutical dosage forms and APIs

Validation Protocol

Production of sterile dosage forms small volume and large volume.

Languages:

English Fluent

Certifications:

QC certificates from BEGECA Germany

Quality control and process validation,

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

Sterile production SVP and LVP 10+ years

Production Tablets capsules and liquid orals 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

Croda Inc. PA - Feb -May 2024

Sr. QC/QA Analyst

My job involved IQ, OQ. And PQ of analytical instruments like.

HPLC GC FID, UHPLC, FTIR ICPMS NMR and UV/VIS Spectrophoto meter and commissioning laboratory

Utilized tools like Minitab for Statistical Process Control (SPC), Gage R&R studies, and Six Sigma methodologies to assess datasets and ensure process optimization, cycle time reduction, and continuous improvement.

Improved production processes by identifying inefficiencies, optimizing workflows, and implementing corrective actions to enhance quality and reduce cycle times.

Conducted aseptic gowning procedures to maintain cleanliness and sterility, ensuring compliance with GMP and safety standards across all critical production areas.

Developed and executed protocols for equipment like Optima Washers, Filler equipment, and Genesis Capper, supporting scheduled projects and enhancing operational efficiency.

Organized and analyzed data using MS Office Suite, ensuring accuracy in records and supporting decision-making with comprehensive data organization for process improvements.

Addressed process issues through root cause analysis and collaboration with cross-functional teams, implementing preventive measures and driving continuous improvement in production lines.

Monitored Change Control process to manage modifications, assessed potential risks, and ensured compliance with Standard Operating Procedures for high-quality outcomes.

Conducted PFMEA for risk assessment, and implementing corrective or preventative actions to improve equipment and processes effectively.

Managed quality control procedures, maintaining lab instruments, calibrating and validating equipment, and ensuring logbook maintenance, ensured adherence to GMP standards.

Performed validation activities for instruments and new systems, troubleshooting equipment issues, managing out-of-specification (OOS) investigations, and conducting root cause analysis for non-conformances.

Monitored QC lab operations, including testing, review of batch records, equipment scheduling, ordering, and inventory management, ensuring workflow and stock levels.

Prepared and maintained infrastructure for lab, including developing schedules for testing and equipment calibration, ensuring resources are available for continuous operations.

Conducted internal quality audits, addressed audit findings, and tracked quality objectives, worked with HR platforms for assignments and feedback, conducting periodic reviews to enhance overall quality processes.

Seqens Pharma Solution 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.

Improved processes by identifying and addressing production issues, focusing on efficiency enhancements within the Filling Lines and other production processes.

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.

Managed Corrective and Preventive Actions (CAPA), ensuring timely resolution of non-conformances through structured investigations and implementation of corrective measures.

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.

Performed Stability tests on all products produced in company. Implemented CGMP.

Validation of analytical methods and production processes.

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

Reviewed BMR and QC Reports. Practicing GLP

Worked 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

Production 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

Implemented Lean Six Sigma methodologies and maintain QMS to drive process efficiency, reduce waste, track key performance indicators (KPIs), and ensure alignment with quality objectives.

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

Customer/Consumer complain.

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.

Conducted aseptic gowning and adhered to GMP standards, ensuring high-quality practices in a controlled environment.

Reduced cycle time and costs by optimizing protocols, including the use of Filler equipment, to streamline filling processes.

Organized and analyzed data for scheduled projects, applying the MS Office Suite to maintain records and evaluate performance metrics.

Created and executed protocols to ensure adherence to Standard Operating Procedures (SOPs) and enhance the quality control of production.

Addressed process issues and took corrective or preventative action for equipment, following the Change Control process and using risk assessments such as PFMEA to maintain compliance and safety.

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

Production 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

Manager 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 - 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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