Quality Assurance Manufacturing

Dilip Kr. Sinha Mailing Add:

B.Tech. (Biochemical Engineering) The MERIDIAN Appartment,

Flat No-179, Block No- 30, Mob No: +27-849****** A.G. de. Witt Drive, Solheim,

E-Mail:***********@*****.*** Germiston, Bedford View,

***********@****.*** Johannesburg, South Africa

To further my technical skills solve interesting challenges, and to excel in any job assigned, to become an asset to organization by fulfilling both the company’s and personal objectives.

Presently working with U.S. based Consultancy Company SEMLER RESEARCH CENTER and appointed for giving service to ADCOCK INGRAM HEALTHCARE (PTY) LTD. Pharmaceutical Company in Johannesburg, South Africa.

Period : 14th April 2011 to Present.

Designation : Consultant (Quality Assurance & Project Engineer).

Job Profile:

● Review of all GMP documents/ activities of clients such as:

R&D, Project & Plants: Deviation, Change control, Process validation protocol, Method

validation, Stability study protocol, Exhibit and executed BMR, BPR.

● Providing technical support to manufacturing site while implementation of Quality management

systems. Implementation of CAPA & Change control.

● Review and finalize Batch manufacturing and Process validation protocol of Oral Solids &

liquids product under cGMP compliance.

● Review and finalize URS document for purchasing of Manufacturing and laboratory equipments.

● To prepare and finalize Equipment Validation/Qualification protocol and report (DQ, IQ, OQ &

PQ) of manufacturing & Laboratory equipments.

● Water system validation (Purified water), HVAC/AHU system validation and prepare its protocol

and report.

● To conduct the Self inspection & perform the GAP analysis. Investigation of market complaints.

● Implementation of key SOP at all locations. Documentation preparation, execution and control.

● To handle the Procurement, Designing and commissioning of all Manufacturing and laboratory

related equipments.

Previously worked with Export oriented MNC Pharmaceutical Company KOPRAN PHARMACEUTICAL LIMITED.

Period : 1st Sep 2008 to 9th April 2011.

Designation : Senior Executive (Quality Assurance & Project).

Job Profile:

● To perform all activities related to Quality assurance like documentation control, SOP

writing, Review of documents for correctness and compliance.

● Monitoring of In-process Quality assurance activity for the manufacturing of solid dosage

forms like Tablet, Capsules, Dry Syrups and Active Pharmaceutical Ingredients.

● To prepare Process validations protocol and report of Solid dosage forms (Tablet, Capsule Dry

syrup) and API’s under cGMP compliance.

● To handle all Deviation, Change control, Out of specification, CAPA and QMS systems.

Participate in the investigation of deviation related to product manufacturing.

● To conduct Internal and external audits. Planning and execution of Vendor audit, vendor

selection, vendor rating and assessments.

● To organize and conduct the Self inspection and/or Quality audit that regularly appraises the

effectiveness and applicability of the quality assurance system.

● To perform Equipment Validation and Qualification (DQ, IQ, OQ & PQ) of manufacturing &

Laboratory equipments and to prepare its protocol and report.

● To handle the Procurement, Designing and commissioning of all Manufacturing equipments and

laboratory related equipments.

● Planning and executing validations under cGMP compliance. Water system validation (RO &

DM water), AHU/RLAF/HVAC validation and prepare its documentation.

● Equipment maintenance monitoring and review. HVAC system monitoring and review.

● To conduct and handle the current needs of “Training” with respect to Current GMP, GLP,

Safety & Hygiene. Prepare training matrix and training calendar.

● To prepare the Standard operating procedure (SOP) under cGMP norms in line with regulatory

requirements.

● Preparation of Standard Manufacturing Procedure (SMP) of solid dosage forms (e.g. Tablet,

Capsules and Dry syrup etc.). Prepare and review of Batch manufacturing record.

● Monitoring of Microbiological assay of Environment monitoring, Water system assay and review

of related document.

Previously worked in Mumbai based Pharmaceutical Company ALKEM LABORATORIES LIMITED.

Period : 30th Aug 2004 to 29th Aug 2008.

Designation : Sr. Research Scientist (Executive, Biochemical Engineer)

Job Profile:

● Upstream processing of raw materials.

● Downstream processing of product includes Micro filtration, Ultra filtration, Nano Filtration,

Centrifugation, Carbon treatment, Rotational Vacuum evaporation and others techniques.

● Process design, Process development & Optimization of critical parameters.

● Bioreactor handling and Analyze how to interpret the data collected from bioreactor

instrumentation.

● Study of cell and product kinetics and Scale up.

● Validation and Qualification of all laboratory equipments and Calibration of critical instruments

as per schedule.

● Working with Resin and chromatography column to separate a particular component from an

Oligosaccharide mixture.

● Protein purification, screening and separation.

● Procurement, Purchasing and commissioning of all laboratory and production plant related

equipments.

● Preparation of Technical presentation documents of ongoing projects, Market survey, Patents and

literature search.

● Graduated as Bachelor of Technology in Biochemical Engineering from Harcourt

Butler Technological Institute (C.S.J.M. University), Kanpur in 2003 securing

56.6% marks.

Total work experience of 6 years and 10 months in the following areas:

● To handle Quality management system (Deviation, Change control, CAPA, Failure

investigation).

● To Perform and execute Process validation of Solid dosage forms (Tablet, Capsule, Dry syrup)

and Active pharmaceuticals ingredients (API’s) and prepare its protocol & reports.

● Equipment qualification and validation activities including development and review URS’s

Master plan, FAT, SAT, DQ, IQ, OQ and PQ documents.

● To execute Water system validation, AHU, HVAC, RLAF validation and prepare its report.

● To perform all activities related to Quality assurance like documentation control, SOP

writing, review of documents for correctness and compliance.

● Design and execute experiment, and analyze interpret data to make sound technical

recommendations on product and process issues.

● Process design, Process development and Process optimization & critical parameters.

● Fermentation / Scale up work. Antibiotic fermentation and its purification.

● Downstream processing and Up scaling trouble shooting.

● Technology transfer from laboratory scale to production scale.

● Scientific and Technical presentation.

● Gel Electrophoresis, Dialysis Techniques, UV & IR Spectrophotometer analysis.

● HPTLC (High Performance Thin Layer chromatography) analysis.

● Filtration Techniques (Micro filtration, Ultra filtration and Nano filtration).

● Bioreactor handling, Rotational vacuum evaporator.

● Moisture content analysis (Karl Fischer), Viscosity measurement (Visco Meter).

● Chromatography Techniques like: Paper chromatography, Thin layer chromatography,

Resin chromatography.

● Isolation and cultivation techniques of Microorganisms.

● Lupin Laboratories Limited

Tarapore, Mumbai in 2002 (3 Months).

Production of anti-TB Antibiotic (Refamycin) and its downstream processing.

● Alkem Laboratories Limited

MIDC, Taloja, Mumbai in 2001 (3 Months).

Plant Design Project: Production, Purification its Process flow design and Plant designing of Antibiotic RIFAMPICIN (Anti-Tuberculosis drug).

Seminar Present: Production and purification of new Antibiotic Semi-synthetic

PENICILLIN for diabetic patients.

Equipment Design Project: Designing of Shell and Tube HEAT EXCHANGER and Plate type HEAT EXCHANGER for the use in Alcohol and Pharmaceuticals industries.

1. Conference attended on “A Global Perspective of Bio-Therapeutics Medicines” on June 2006 in Grand Hayatt, Anderi, Mumbai organized by ASSOCHAM.

2. Seminar participated on “Pharmaceutical Water System Validation” on 4th March 2011 in Sunville Banquet Hall, Worli, Mumbai organized by Indian Drug Manufacturers Association (IDMA).

3.

● Languages : BASIC Programming and C++

● Operating Systems : Microsoft window 98/2000/XP/Vista/Window 7

● Application Tools : MS office / Photoshop/Auto CAD

● Hardware : PC Components Assembling

● Have sharp information browsing capability on Internet (Boolean searching).

● Acquainted with Patents database searching.

● Project Planning/Designing.

● Strong passion for Process development, Designing and commissioning work.

● Process Validation & Qualification of Equipments.

● Problem solving abilities, ability to work in a diversified group, fast learning ability.

● Good communication and interpersonal skills.

● Good Mathematical and Analytical ability.

Father’s Name : Nand Kishore Prasad

Nationality : Indian

Marital Status : Single

Language Proficiency : Fluently in English & Hindi

Hobbies : Photography, Music, Playing Chess and Cricket.

Passport No. : G6383022

Contact No. : +27-849******

E mail Id. : ***********@*****.***

I hereby declare that all the above information given by me is true to the best of my knowledge and belief.

Thanking you Your Faithfully

PLACE:

Johannesburg, SOUTH AFRICA (DILIP KR. SINHA)

S. No. Company Name Projects Job Responsibilities

1. Alkem Laboratories Limited (Mumbai) Process Development:

1. Fructooligosaccharide

(Low calorie sweetener)

2. Alpha Amylase

(Digestive enzyme)

3. Bromelain

(Digestive enzyme)

4. Isomaltooligosaccharide

(Sweetener)

5. Omega-3 Fatty Acid

6. Saccharomyces boulardi

7. Coenzyme Q10

Plant Designing:

Plant Design & Process

Flow design for

Fructooligosaccharide

Production

Audit Faced:

USFDA (America)

ANVISA (Brazil)

● Process conceptual design and development.

● Process simulation study through lab scale &

pilot scale experiment.

● Process optimization & critical parameter.

● Operation of Bioreactor and Instrumentation.

● To execute operational and Performance

Qualification of all laboratory equipments.

● Study of cell and product kinetics,

Bioreactor design and Scale up.

● Down Stream processing

● Plant design and calculation

● Preparation of process flow diagram.

● SOPs preparation under cGMP norms.

● Production protocol preparation.

● Technology transfer from lab scale to

production scale.

● Validation and Qualification of all laboratory

Equipments

● Calibration of critical instruments.

2. Kopran Pharmaceutical Limited (Mumbai) Audit Faced:

1. MHRA (UK)

2. MCC (SA)

3. TGA (AUS)

4. NDA (Uganda)

5. ANVISA (Brazil)

6. WHO (India)

7. Oman

8. Nigeria

9. Kenia

10. Malaysia

● Monitoring of In-process activities during

manufacturing of various dosage forms

(Tablets, Capsules & Dry syrups)

● Quality management system (Deviation,

Change control, Failure Investigation,

Corrective action & Preventive action).

● Perform all manufacturing & laboratory

related equipments Qualification (IQ, DQ,

OQ & PQ).

● Water system and HVAC validation.

● Process Validation of solid dosage forms

(Tablets, Capsules & Dry syrups) & API’s.

● Preparation of SOPs under cGMP norms.

● Preparation of Standard Manufacturing

procedure of various dosage forms (e.g.

Tablet, Capsules and Dry syrup).

● Interacting with manufacturing & Engg.

personnel in planning for the construction,

alteration, renovation, and purchase of

equipments.

● To conduct the current needs of “Training”

with respect to GMP, GLP, Safety &

Hygiene.

● To organize and conduct the Self inspection.

● Vendor audit for API & Excipients, Vendor

rating & Vendor Assessments.

3. Adcock Ingram Healthcare Pvt. Ltd. Johannesburg, South Africa. (Consultant for Semler Research Center) Audit Faced:

1. MCC (South Africa) ● Review of all GMP documents/ activities of

clients such as: R&D, Project & Plants:

Deviation, Change control, Process

validation protocol, Method validation,

Stability study protocol, Exhibit and

executed BMR, BPR.

● Review and finalize URS document for

Manufacturing & laboratory equipment

purchasing.

● Review and prepare Equipment qualification

(IQ, DQ, OQ, PQ) for Manufacturing and

Laboratory related.

● Purified Water system and HVAC system

Validation document.

● Review and finalize Process Validation

document of Solid & Liquid Oral dosage

forms (Tablets, Capsules Liquid syrup &

Dry syrup)

Contact this candidate