Quality Assurance Control

MOHAMMMAD YASIN

Objective:

To use my current expertise in the Field of Pharmaceutical Quality Control, Assurance, Analysis, and Regulatory Affairs, GLP, Validation, Stability studies as per ICH Guidelines, R&D etc. for the welfare of entire human being, extract the best out of my potential and convey to others for more innovations. My strength & ability along with my present work experience and sense of responsibility, positive attitude will help me to handle challenging tasks.

I am young, confident, hardworking and reliable person with full professional commitment. I compose a friendly disposition with a good sense of humor. I can work well under pressure, either as an individual or a part of a team. Combined with my dedication, determination and hard work, the same shall help me go up the specialist ladder. Personal traits:

Self initiator, devotion and dedication to work, work in a challengeable atmosphere, proven administrative ability, communicate effectively with people from other cultures, cheerful under pressure, remain enthusiastic ever in the face of frustration, persistence, personal contact, self reliance and confidence are those factors which have helped me to maintain a consistent record of achievements. I can communicate well in English, Urdu, and Pashto.

Personal Data

Father’s Name: Hajji Nawab

Date of Birth: Feb. 06, 1979.

Nationality: Pakistani

Mailing Address: Village Sher khana, P/O Palai, District Malakand, Khyber Pakhtunkhwa, Pakistan.

Marital Status: Married.

Domicile: Malakand, Khyber Pakhtunkhwa.

Present address: Custom House, Aqina, Faryab, Afghanistan. Academic Qualifications

Contact me at:

Pakistan No: 009***********

Email: **********@*****.***

Degree/Certificate Institute Session

M.Sc Chemistry

(Analytical/Inorganic)

Department of chemistry Hazara

University Mansehra, Pakistan.

2004-2006

B.Sc (Botony, chemistry &

Geography)

Govt College Thana, Malakand

/University of Peshawar, Pakistan.

1999-2001

F.SC (pre-Medical)

Govt College Thana Malakand, KPK,

Pakistan.

1996-1998

SSC (Science Group)

Govt High School Palai, Malakand

KPK, Pakistan.

1994-1995

Instrumental Skills

1. GC(Gas Chromatography )

2. HPLC (High performance Liquid chromatography)

3. UV-VIS Spectrophotometry

4. AAS (Atomic Absorption Spectrophotometry)

5. pH and Conductivity Measurements(pH Meters)

6. Moisture Analysis (Moisture Analyzers)

7. Hardness Testing

8. Dissolution Testing

9. Disintegration Testing

10. Acidity and Alkalinity Testing

11. Different type of Titrations Tests

12. Weight variation and volume variation Tests

13. Friability(Fragility Testing)

14. Density and Viscosity Testing

15. Distillation Testing

16. Freezing point Testing

17. Cloud point and pour point testing

18. Copper strip corrosion test

19. Octane number test

20. Cetane number and cetane index test

21. Vapor pressure test

22. Volatility and residue tests

23. Aromatics and saturates tests

24. Sulfur contents with XRF

25. Lead contents with XRF

26. Water determination with Karl fisher inst.

27. Flame Photometer

28. Polarimter and refractive index

29. Polari meter

30. Analytical balance handing and operations

31. Ovens

32. Water bath

33. Autoclave

34. Hot and cool incubators

35. Environmental stability testing chambers.

36. Anemometer

37. Electric and manual desiccators

38. Colony counters

39. Water distillation and R/O plants

40. Different sterilizers

Professional Skills

Production of Quality, Economic and patient’s friendly medicines. As a part of pharmaceutical R&D, Quality, casting and Validation teams I have delivered the best quality, patient’s and manufacturer’s friendly economic medicines. The following are some of the duties performed.

1. Have established QC Lab. Production sections (tablets, capsules, dry suspension, dry powder injection, liquid injectin) for a new born unit. 2. Have done R&D for many newly launched products keeping in view the best formulations with pilot batches tested for their quality, stability studies, chemical, physical and microbiological analysis.

3. Have employed new and updated technologies for reducing the cast and strengthen quality of already marketed products. Examples are sustained release Diclofeanc sodium was formulated with latest polymer to reduce the cast and making it sustained releasing properties more effective against competitor. 4. Have developed economical analytical testing methods, which have reduce the overall cast in terms of its less time consumption and affordability in available resources.

5. Have performed process validation to ensure the batch to batch reproducibility of quality and yield.

6. Have successfully delivered quality products as per marketing team demands; have made possible the timely delivery of bulk finished products. 7. Have validated and certified vendors, for raw materials after performing the qualitative and trail testing keeping in view the best, economical, and timely practices of vendors.

8. In coordination with the engineering department have produced many cast effective items in-house instead of purchasing costly, imported items. Examples are R/O water treatment plants, conveyer belts, digital hygrometers for sterile clean rooms, portable dehumidifiers, stability testing chambers. 9. Regarding the packaging materials, I have always produced the best designs as per marketing team suggestions, have done the proof reading, translation of leaflets from English to Urdu (for afghan parties).

10. Have coordination with ministry of health for regularity affairs, registration of new molecules, licensing etc. Have appeared in front of Quality control board of MOH, for resolving the cases made by Federal Inspector of Drugs. 11. Have trained the subordinates as to produce quality human resource for best GMP, GLP practices.

As Head of Quality Control Department

As the head of the quality control department, I have developed standard analytical procedures, standard manufacturing procedure, product specs., standard operating procedure, as per recommended pharmacopeias I have practice the following instruments to assure the quality of medicines prepared under my supervision. With the above instruments I have performed the following quality control testing.

• Routine testing of tablets( final mix powder, cores, coated tablets): 1. Physical inspection(visual for foreign particle) 2. Moisture contents.

3. Friability test

4. Dissolution test

5. Disintegration test

6. Wt. variation

7. Hardness test

8. Seal integrity test for blister

9. Chemical assay

• Routine testing of capsules:

1. Physical inspection(visual for foreign matter)

2. Moisture contents

3. Weight variation test

4. Disintegration test

5. Dissolution test

6. Chemical assay

• Routine testing of dry powder suspensions:

1. Physical inspection (visual for foreign matter) 2. Moisture contents

3. Wight and volume variations

4. pH test

5. Reconstitution with recommended volume of solvent 6. Chemical Asaay

7. Chemical Assay decline observation for 7 days.

• Routine testing of dry powder injection(cephalosporin & general) 1. Physical visual optical checking of powder for foreign matter. 2. Vial sealing integrity test

3. Moisture contents

4. Weight variation

5. Reconstitution with solvent observing solubility and black particles. 6. pH test

7. chemical assay

8. Sterility testing, observing microbial growth for 14 days.

• Routine testing of liquid injection.

1. Visual optical checking for black and white particles 2. pH Test

3. volume variation test

4. chemical assay

5. sterility test (microbial growth for 14 days)

Besides the above testing, I have performed complete raw material testing as per USP, BP, and IP etc. Also have performed the required testing of packaging materials as per laid down SOP’S.

Pharmaceuticals Experiences (in terms of years)

Designation Organization Period

Quality Control

Analyst/Quality Assurance

Officer

SB Pharmaceutical Islamabad Pak. Jan 2001 –SEP.2003 Senior

Quality Control Analyst

Global Pharmaceutical Islamabad Pak. Feb2006- March 2009 Quality Control

Manager

Wnsfeild Pharmaceutical Hattar Pak. April 2009- January .2011 Quality Control

Manager

Well borne pharma Hattar kpk, Pak. Dec. 2011 Feb 2013. Senior chemist Geo Chem. Afghanistan March 2013 ---April 2014 QCM Makson Pharma Islamabad Pak. May 2014 Till Date Job description as Manager

To make the control of every process taking place in the production unit.

To train the subordinates and all concern for cGMP, GLP, ICH guidelines to strengthen their capabilities vs. GMP compliance.

To timely deliver any assignment given by the management.

To make sure that positive coordination and interpersonal skills are maintained at every step of the required activity.

Extreme and strong follow-up of the tasks given under pressure.

To dilute the work pressure in a quality manner.

Always look positive when any personality clash is expected with the boss, avoid aggressive and bad tones.

Identification and solution of problems.

Try to be economical, and qualitative in limited resources.

To make bold and positive brave decisions.

To ensure the quality of products manufactured in my supervision.

To look after all the activities performed in the laboratory.

To train, supervise and guide the subordinates as per GLP rules.

To manage all the required resources necessary for lab. Activities.

To perform and check all the documentations regarding Ministry of health of Pakistan, regularity affairs,routine analysis of drugs, making and reviewing SAP’S, SOP’S,SMP’S etc.

To conduct routine and surprise visits of drug inspectors and maintain records.

To construct and submit registration files for new drugs.

To do R&D for newly launched products.

To develop and validate new and economical analytical methods.

To maintain routine development projects as per requirements of GMP.

To make sure rapid and consistent analysis of raw materials and finished products as per market demands.

Job Description as Quality assurance Officer:

Collect routine samples of raw materials, solvents, packaging components, and capsules, worked in process bulk, in-process operations, product labeling and finished products as directed with close supervision.

To strictly assure the quality of manufactured product as against GMP Compliance.

Has conducted inspections and physical test of raw materials, during manufacturing and packaging component samples and prepared test reports.

Performed releases of packaging and production operations and staged materials.

Supervision of discrepancies or deviations. Operated and maintained sampling, measuring, proof reading and weighing equipment.

Developed local processes and procedures to ensure compliance with corporate quality standards related to Quality System management. Quality standards, and take corrective action if necessary.

Sample products to determine whether they meet specifications a

Analyze quality assurance data and make recommendations for improvement.

Inspected and Conducted periodic inspections of all drug storage and usage areas. Correct discrepancies and maintain inspection reports. Professional behavior

Well behaving in all circumstances, even in enormous pressure.

Can understand and solve the professionally originated complicit.

Always communicate in positive tones even in response to bad tones.

To make sure that positive coordination and interpersonal skills are maintained at every step of the required activity.

Extreme and strong follow-up of the tasks given under pressure.

To dilute the work pressure in a quality manner.

Always look positive when any personality clash is expected with the boss, avoid aggressive and bad tones.

Identification and solution of problems.

Try to be economical, and qualitative in limited resources.

To make bold and positive harsh decisions.

To ensure the quality of drugs manufactured in my supervision. Computer and language skills

Computer Skills: MS Office and common Software & hardware manipulations, Internet usage for email and data surfing etc.

Language Skills: Fluency in English, Urdu and Pashto (Mother Tongue) can understand Dari.

Contact this candidate