www.dereak.com for Medical Pharmaceutical Consultations Saudi Arabia : Clinical Epidemiologist

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Dereak for Medical & Pharmaceutical Consultations KSA : Clinical Epidemiologist/Epidemiologist
Company Name : Dereak for Medical & Pharmaceutical Consultations
Company Location : KSA
Designation (of vacancy) : Clinical Epidemiologist/Epidemiologist
Company E-mail ID : info@dereak.com
Company Website : www.dereak.com

Job Description, Candidate Profile, Company Profile, Company Address :
DUTIES :
1. Performs complex epidemiological studies in field of pharmacy and medicine
2. Assisting in devising methods of surveillance, implementation, and analysis of epidemiological investigations or studies;
3. Participating in general data management and report writing for epidemiological studies and investigations.
4. Designs surveys and questionnaires to collect data,
5. Conducts studies designed,
6. Performs statistical analyses of study data, plans and organizes new methods for obtaining additional health data and for improving the reliability and validity of health data being collected,
7. Assists in the formulation of hypotheses,
8. Assists in the formulation of recommendations,
9. Provides consultation, educational programs
10. Write publishable articles and papers
11. Perform other duties as assigned.

KNOWLEDGE AND SKILLS :
1. Knowledge of study design and analytic methods.
2. Knowledge of computer manipulation of large datasets.
3. Skill in working with a wide variety of data structures, coding schemes and data sources.
4. Skill in various statistical procedures and in application of advanced analytical techniques.
5. Skill in analysis of large data using SAS and SPSS.

REQUIREMENTS :
1. Male
2. M.Sc. (PhD preferable) in clinical epidemiology
3. Minimum 3 years experience
4. Fluency in English (write, speak)
5. Published in peer reviewed journals

Apply here:
http://www.dereak.com/apply.php?job_...Epidemiologist

Riyadh - Musa Bin Nusair Street

[LIST][*]Phone number : + 966 - 01 - 4645812[*]FAX number : + 966 - 01 - 2177858[*]P.O Box : 7473 Zip Code 21462[/LIST]
Jeddah - Almadinah Street

[LIST][*]Phone number : + 966 - 02 - 6831883[*]FAX number : + 966 - 02 - 6831629[*]P.O Box : 7473 Zip Code 21462[/LIST]
Bahrain - Almuharraq 202 - 136 - Shek Kalefa Bin Salman Street. Office 22

[LIST][*]Phone number : + 974 - 4 - 9886641[*]Email : info@dereak.com[/LIST]

[nahiaali33]

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[Guest-IJT]

VIPUL MISHRA
H No: 2JW/4 NH2 NIT Faridabad (HR),
Delhi NCR, India,
Mob. +918059247407, 9891297414,
E-mail : vipul_onweb AT yahoo.com
: Vipulmishra1984 AT gmail.com

Passport no. H8221694
Date Of Birth: - 25th March 1985

CAREER OBJECTIVE
Seeking a position to utilise my skills and abilities in the “Technical Division QA & RA” Dept. of API /Formulation Industry that offers Professional growth while being resourceful, innovative and flexible.

EDUCATION
Masters Degree in Science from Barkatullah University, Bhopal .

ACADEMIC RECORD
Degree Year Institute Board/University Percentage
M.Sc. (Biotechnology.) 2007 Barkatullah Barkatullah 66%
B.Sc.(Chem) 2005 Barkatullah Barkatullah 60%
12th (10+2) 2002 C.G. Board Raipur 61%
10th 2000
M.P. Board Bhopal 66%

OTHER QUALIFICATION
1. Postgradute diploma in Drug regulatory affairs Recognized by Govt. of INDIA& affiliated to Jamiya Hamdard University Delhi Jun 2008
2. MBA in International Business management from Magadh
University bodhgaya (Jun 2009).

OTHER INFORMATION
Seminar Work Done in M.Sc. : Instrumentation

EXTRA CURRICULAR ACTIVITIES
1. Attended training on Calibration conducted by INSTO-TECH Institute Mumbai.
2. Help in “SWORD OF HONOUR” (UK) Audit Document preparation
For HEALTH, SAFETY & ENVIRONMENT Dept. in Cipla Ltd.

WORKING EXPERIENCE
1. Dr.reddys Labs Ltd. (College Training Only)
Hyderabad
Duration : 6 Months Training
Job Responsibility :Q.C. Chemist
Sampling, Analysis of Raw materials, Intermediates, Semi- Finished & Finished Products of tablets, Ointments & Creams
Instrument Handled as :
KF- Titrator, Potentiometer, UV-VISIBLE Spectrophotometer, pH-Meter, Disintegration, Polarimeter, Refractometer, Friability meter, IR-Moisture Balance, Thin layer & Paper Chromatography, Microscope.

2. IND-SWIFT LABORATORIES LIMITED
EPIP PHASE-II BADDI (HIMACHAL PRADESH).
Duration : 1.5 Year
Job Responsibility : Formulation Q.A.
Good understanding of Quality systems of the organization & successfully ,
Co-ordinately woks in various International Vendors Audits like USFDA,MCC , MCA , WHO .And many others Regulated & Non-Regulated Pary Audits .

Consistently working in Review & Compilation of BMRs, BPRs, Q.C.Reports And Release of the batches ; Preparation & Updation of SOPs and Good Documentation Practices .
Simultaneously works in Scheduling & Preparation of Class Room Trainning , Preparation of Minutes & Reporting to Unit Head .
Online Inprocess Checks, BMRs, BPRs, Reviewed.
Regular GMP Round in the Tablet, Capsule & Injection Mfg. Areas.

Exp. In Validation :
1) Validation Sampling plan preparation & online Sampling
At different stages of Mfg of Tab. & Injection .
2) Cleaning Validation
3) Done R & D Batches Formulation.
4) Dispensing Activity.
Well handled Audits Documentation.

3. NESTOR Pharmaceutical Ltd,
Faridabad HARYANA
Duration : 1.2Years
Job Responsibility :Plant Regulatory Affairs in API & Quality Assurance
Regulatory Affairs :-
[ PRC : Product Registration Cell ]
1] Preparation of DMF/ CTD
(Drug Master File / Common Technical Document )
2] Preparation of TIP (Technical Information Package)
3] Preparation of Annual Updates for registered DMF product
4] Handling of US or other Countries Deficiencies & Queries
5] Daily communication (mails) Response & follow
Exp. In Validation :

1) Process Validation includes Dryning, Blending &
Micronisation of final API
2) Preparation of Sampling Plan, Updation, Reporting
of Validation Protocols & Reports.
3) Done Regular & Non-Routine Validation as per Validation schedule.
4) Cleaning Validation

Documentation :
1) Preparation & Updation of Equipment Cleaning SOPs,
Generals Procedures & Eos.
2) Preparation & Comparison of Master Process Data sheet new Mfg Process of New, Final & Intermedite APIs , Handling of Deviation & Change Control
3) Preparation of Validation Reports for Final & Intermd.
APIs a) Retrospective Validation Reports
b) Concurrent Validation Reports
c) Annual Reports
d) Process Validation Reports
4) Reviwed & Compliace of Process Data Sheets
5) Scheduling & Preparation of Class room Trainnings and Reporting of Trainning Minutes.
6) Audits Documents Handling & Audit Report preparation

4. CORAL DRUGS PVT. LTD., DELHI
Duration : 1 Years ( Continuous)
Job Responsibility :Corporate Quality Division
Role: International Auditor
Position : Executive – R.A. & Q.A.
1. Performed 62 Vendor Audits for API & Packaging Materials.
2. Performed 6 International Audits
3. Approvals/ Rejection of Vendors for API, RM & Packaging Materials
4. Preparation, Reviewing of Vendor Dockets, Technical Documents
5. Preparation of Guidance, SOPs
6. Daily communication (mails) Response & follow up

[Guest]

Sub : Application for the post of QA - Analytical Assurance (or) Quality Control Department
Dear Sir / Madam,
I acquired 7+ years experience in Pharmaceuticals in Quality control Department. Presently i am working with Aurobindo Pharma Ltd., (Formulations) as a Team Leader (Sr.Executive -E4 Level) - QC – Analytical Compliance Team.
I request you to consider my application and provide me an opportunity in your esteem organization. I shall do my best. I await your favorable response and looking forward for an early appointment for an interview with your good self, where I can explain more about myself.
Thanking you,
With Regards,
M.JANARDHAN
Muga.Janardhan
Email : mjr_qualitycontrol AT yahoo.co.in , mjraurobindoqms AT gmail.com
mjpharmaceuticals AT gmail.com
________________________________________
Career Objective :
Able to work on initiative and as part of a team, proven leadership skills in the field of Analytical Assurance and Quality control involving managing, developing and motivating teams to achieve their objectives, first-class analytical, design and problem solving skills, dedicated to maintaining high quality standards
Organizational Details :
- Total Experience : 8 Years
- Areas of Interest : Analytical Assurance (or) Quality Control Department
- Currently associated with Aurobindo Pharma Ltd., Unit-III – Formulations, Hyderabad as a Team Leader (E4 Level) – QC - Audit &Analytical Compliance Team from April 2008 to till date engaged in manufacture of Tablets, Capsules and Orals dosage forms.
- Worked as a Gland Pharma Ltd., Injectable Formulations, Hyderabad as a Executive from May 2004 to May 2008 which is manufactures of APIs and Injectable formulations.
Academia :
- M.Sc. Applied Microbiology from Periyar University, Salem, T.N (2002 – 2004)
- M.Sc. Chemistry from Nagarjuna university, Guntur, AP-Disst.Edutn (2005-2007)
- B.Sc (Chemistry) from S.V. University, Tirupathi, AP - (1999-2002)
- 10+2 from A.P.R.J.College, Nellore (Venkatagiri), AP – (1997-1999).
- S.S.C from A.P.R.School, Nellore (Gandipalem), AP – (1997).
Major Responsibilities :
Analytical Review : Quality control and Microbiology Department
- Analytical Review of Finished product, raw material, Process Validation, In-process, Microbiology data recording and checking of analytical results and reposts.
- Review & Monitoring of Calibration repots of Laboratory Instruments like : HPLC, UV-Vis Spectrophotometer, Dissolution Test Apparatus, Tablet Friability Tester, Hardness and Thickness Test Apparatus, Analytical Balances and Disintegration Test Apparatus etc.
- Review of Validation protocols & Reports and Stability data.
- Review the Change controls, OOS, OOT, PNCs, investigations related to process and Documentation Control review.
- Empower Software, Daily Audit Trial review, Backup of the Chromatography data.
- Preparation & Review of Dissolution Profiles Trends for submission of Bio-Studies.
- To review the Media Stock register & consumption and Microbiology analytical reports as per release criteria.
- Review of trends & summary reports for Environment & water.
- Allotting PNC No. for Process Non Conformance through QMS (Quality Management Systems) happing during Instrumental Analysis and analytical error’s in the Lab and overall lab compliance With CGLP.
- Facing customer and regulatory audits and audit follow-ups.
Aurobindo Pharma Ltd., Unit – III – Formulations, Hyderabad.
"Aurobindo will be good formulation company with the largest Active Pharmaceutical Ingredients manufacturer under CGMP qualified plant."
Aurobindo's five units for APIs and four units for formulations are designed for the regulated markets.
Aurobindo is among the largest 'Vertically Integrated' pharmaceutical companies in India, Aurobindo has robust product portfolio spread over major product areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic with approved manufacturing facilities by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-Brazil for both APIs & Formulations and has Global presence with own infrastructure, strategic alliances, subsidiaries & joint ventures.
Job Responsibilities at APL
- Supporting to analytical team to reach monthly high targets.
- Manpower handling / allocation of work to chemists as per schedule and data documentation.
- Preparation of quality report on monthly basis
- To monitor the QC Department – analytical complies for all products developed, as per regulatory requirements.
- Management of Chemicals and Reagents, HPLC columns Procurement and Stock maintenance.
- Laboratory investigation for OOS / OOT/ PNCs.
- Handling of Internal audits, change controls, investigations related to process and product failures, market complaints etc.
- Coordinate with QA/RA/Production for day-to-day activities.
- Handling & Solving the problems of Analylitical & Instrumental Troubleshooting of QC instruments and discuss with Superior’s take the suggestions.
- Perform the Multimedia Dissolution Profile Different Products and compare to F1, F2 Values.
- Preparation and Revision of Quality documents such as "SOPs", "STPs" and "GTPs"
- Instrumental and Chemical Analysis of Finished Product, , In-Process, Process-Validation, Raw Material and Microbiology Samples { Blend, Tablets, Capsules and Oral Solutions} Submission batches, Exhibit batches as per pharmacopoeias and in- house standards. Review, Release and Submission of data to QA.
Achievements :
- Successfully completed monthly targets release of finished products.
- Facing & Co-ordinate during USFDA, MHRA, BRAZIL-ANVISA, TGA, WHO and other Customer Regulatory Audits.
- Learning and Implementing GLP, cGMP & GDP.
- Interfacing with Caliber LIMS software (2.0 & 3.0 ver.) for registrations, work allotment, work sheets taking, online entries and review.
Microbiology :
Good knowledge adout of Microbiology Section :
- Preparation of protocols for validation studies related to Microbiological methods.
- Monitoring of Media preparation management and pathogens subculture management.
- MLT Analysis : Microbial testing of Raw materials, Finished products, Stability, Process Validation, R&D and packing materials as per USP/EP & Harmonization method.
- Handled preservative challenge test of oral solutions like antiretroviral products (USP&EP) methods.
- EMR : Responsible for Environmental Validation, establishing its limit and trend analysis. (Air Sampling & Settle pate Method).
- Cleaning Validations, GPT Test, Drain Points, Personal Biolode.
Gland Pharma Ltd., Injectable Formulations, Hyderabad.
Gland Pharma is a research-focused organization continuously developing niche products for the Indian and global pharmaceutical markets. It has pioneered Heparin technology in India and has a position of leadership in the
GlycosAminoGlycans (GAGs) range of molecules. The companies manufacture Active Pharmaceutical Ingredients (APIs) and inject able formulations for niche segments such as Osteoarthritis, Anti-coagulants, Gynecology, and Ophthalmology.
The Company has world-class & world-scale facilities for injectables, it as an exclusive facility for Small Volume Parenterals (SVPs). Specifically in Pre Filled Syringes, Vials and Ampoules.
Job Responsibilities at GPL
- Responsible for sample inward entry.
- Review of analytical raw data sheets of Raw material, in -process and finished product and Releases as per Specification.
- Analysis of FP, RM, IP, MB, and Stability samples as per pharmacopoeias and in- house standards. Review, Release and Submission of data to QA.
- Responsible of all equipments of calibration records and IQ, OQ and PQ
- Maintain Calibration of all QC equipments.
- cGLP compliance of QC Laboratory.
- Handling Troubleshooting of QC Equipments like HPLC and other instruments.
- Calibration of Instruments and maintaining records.
- Preparation and Review of "SOPs", "STPs" and "GTPs"
- Microbial analysis : EMR, MLT.
- Handled documentation requirements for USFDA, WHO, TGA, ANVISA audit.
- Handling of rejected / recalled materials.
- Identification & Justification of Retainable goods.
Instrumental Access :
Well versed with highly sophisticated Analytical instruments such as :
1) HPLC : High Performance Liquid Chromatography: Agilent-1100 Series, Waters Alliance-2695, 2696(PDA) with Empower-1 and 2 Software and Shimadzu with Class VP.
2) Uv - Vis spectrophotometer : Shimadzu 1700
3) Dissolution Apparatus : Pharma Test, Lab India, Electolab and Daisytek with Auto samplers and Manual.
4) GC : Gas Chromatograph: Shimadzu
5) Other QC Instruments.

Computer Exposure :
- LIMS (Laboratory Information Management System) operations, of 2.0 and 3.0 ver.
- TRIMS (Training Record Information Management System), QMS (Quality Management Systems)
- Application of MS Office, Power point, Internet & E-mail.