Speakers and Advisory Committee

Ahmed Bashtar

Ahmed Bashtar

Quality Assurance Manager

Pfizer Global Supply, KSA

Ahmed Bashtar has +10 years of experience in industrial sector specialised in pharmaceutical manufacturing. He held many posts in different fields e.g. R&D, quality control, quality assurance, Compliance auditing, supplier Quality Management, third parties Management, in Market Quality and supply chain management. He experienced the staff level and management level as well.

In addition to that, he has led many projects to enhance product quality, quality systems and inventory control as well. His educational background includes:

• Master of Business administration and global economics
• Master degree of quality management
• GSK Certified auditor
• Bachelor degree of pharmaceutical sciences
• GSK certified black belt six sigma
• GSK certified green belt six sigma

Dr. Amer M. Alanazi

Dr. Amer M. Alanazi

Associate Professor and Pharma Industrial Consultant

King Saud University, KSA
Biswajit Mitra

Biswajit Mitra

Executive Vice President & Chief of Manufacturing

Jubilant Life Sciences, India

Biswajit holds Bachelor degrees in Chemical Engineering and Chemistry. He is also a Chartered Engineer and holds a degree in Operation Management.

He brings with him 25 years of experience in Life sciences, managing pharmaceutical products and services business globally - with an emphasis on business/operational excellence, strategy, technology management, programme management/CRM, geographical expansion of business in the area of Active Pharmaceuticals Ingredients (API), Custom Development, and Pharma (Formulation).

Biswajit has previously held Senior Management positions in European Multinationals, British-American Joint venture company & leading Business houses in India e.g. Sandoz, Novartis, Laporte UK, Nicholas Piramal, Dr Reddy's, Jubilant & Chemo in Spain.

He is the recipient of various International & National awards such Golden Peacock Award 2010 (London), Platinum Award in Indian & Asian Manufacturing Excellence (World Class Mfg) by Frost Sullivan, Recipient of various other awards in Business Excellence; Health & Safety; Six Sigma; Engineering Excellences.

Dhananjay Kulkarni

Dhananjay Kulkarni

Director – Plant Operations

Aja Pharma, KSA

Joined Aja Pharma in year 2013, right from the inception of the Project. Presently responsible for the Operations as well as the ongoing Sterile Project. As a Head of Operations, was very much responsible for Planning the capacities for the new Plant. Started my career at Bengaluru, India in the year 1988-89 after completing degree in Pharmacy followed by a Diploma in Business Management. Worked at various capacities in well-known companies in India and CIS countries. Had an opportunity and was very fortunate to work in almost all the dosage forms before heading the production. Prior to relocating to Saudi Arabia in 2005 was serving  as  a Plant Manager at Matrix Laboratories, Nasik, India (Now Mylan Laboratories).

Essam Al Jindy

Essam Al Jindy

Dammam Plant Director

Tabuk Pharma, KSA
Dr. Faisal Al Dail

Dr. Faisal Al Dail

Chairperson, National Committee for Pharmaceutical Industries (NCPI) and Deputy General Manager

AJA Pharma , KSA
Dr. Gautam Samanta

Dr. Gautam Samanta

Vice President, Head of Quality by Design and Technology Transfer

Cipla, India

Dr. Gautam Samanta is Vice President and Head of Quality by Design and Technology Transfer at Cipla Ltd. Previously, he worked at Dr. Reddy’s Laboratories in API development and implemented QbD and PAT in product development. His areas of focus are development of robust product using QbD and PAT and seamless transition of process from R&D to manufacturing using modeling and simulation. He was awarded Ph.D. degree from Jadavpur University, Calcutta. Following his Ph.D. degree, he pursued research as a postdoctoral research fellow at the National Institute of Health Sciences, Japan and then the Texas Tech University, USA. After his postdoctoral research, he joined as a research Assistant Professor at the University of Houston, Texas, USA. He has published more than 50 papers in peer-reviewed international journals including the very prestigious Nature. His work has been cited by more than 5000 researchers. He has also authored 5 book chapters. He is an inventor of three process patents. He is a reviewer of many scientific journals such as Analytical Chemistry, Environmental Science and Technology etc.

Jayakrishnan P.

Jayakrishnan P.

Senior Supervisor Regulatory Affairs - US, EU and GCC Countries

Hikma Pharmaceuticals, KSA
Salah M. AlKhowaiter

Salah M. AlKhowaiter

Director, Quality and Compliance

Saudi Pharmaceutical Industries & Medical Appliances Corporation (SPIMACO), KSA

Salah Mohammad Al-Khowaiter is the director of Quality and Compliance at Saudi Pharmaceutical Industries and Medical Appliance Corporation (SPIMACO ADDWAEIH). In this capacity, he manages an independent quality function in pharmaceutical environment in accordance with the quality policies and corporate objectives. Salah is a valued member of SPIMACO ADDWAEIH’s management team wherein he has been involved within the organisation for about 27 years in service. An integral part of his professional experience in SPIMACO’s quality management is his 11 years’ contribution as Quality Control Manager. His early years began in clinical laboratories in Ministry of Health in Saudi Arabia for about six years.

Salah has been with SPIMACO ADDWEIAH in a significant length of time paying attention in continuous improvement of the quality management system. Most noticeable is his working collaboration with multinational pharmaceutical companies globally in terms of setting robust quality management. He is currently working on strengthening the quality system by introducing an electronic platform to handle Quality Management System and Laboratory System through the utilisation of eQMS and Laboratory Information Management System respectively. His leadership extends to limitless boundaries by introducing the LEAN management principles in Quality Control and influences a step change in the whole quality function. Salah's current engagement is to oversee the Quality aspect of High-Potent and Oncology pipeline of SPIMACO.

Dr. Salman Al-Mishari

Dr. Salman Al-Mishari

Regional Director

International Lean Six Sigma Institute, KSA

Dr. Salman T. Al-Mishari is a practicing Reliability Consultant at SM Engineering Consulting Inc. He has 28 years of postgraduate experience at Saudi Aramco and 5 years as a part time faculty at KFUPM, Saudi Arabia. Dr. Salman’s experience is in the reliability of various types of manufacturing and plant equipment reliability as well as coaching personnel and teaching graduate & undergraduate courses. Dr. Salman is a certified reliability and maintenance professional (CMRP) and also holds a black-belt certification in Six Sigma. He is also a certified Root Cause Analysis instructor.  He received his B.S. degree in Mechanical Engineering from the University of Alabama, USA, his M.S. degree in Engineering Management from King Fahd University of Petroleum and Minerals (KFUPM), Saudi Arabia, and his Ph.D. in Plant Equipment Reliability from the University of Bahrain, Bahrain.

Salem Hammam

Salem Hammam

General Manager

Sanofi, KSA
Sherin Joseph

Sherin Joseph

Quality Manager

Riyadh Pharma, KSA
Syed Abid Hassan

Syed Abid Hassan

Head of Regulatory Compliance

Jamjoom Pharmaceuticals, KSA
Dr. Wasif Azeem

Dr. Wasif Azeem

Director Quality Operations

Jamjoom Pharma, KSA

Vast progressive experience spanning around 30 years with Pharma Industry / academia. Dr. Wasif Azeem holds Ph.D. degree in Drug Chemistry & working as "Director Quality Operations" in Jamjoom Pharma KSA for last 6 years. He had long career with Abbott laboratories as role of senior managements. Diverse portfolio has built in-depth knowledge of Quality Management system & completely acquainted with the global cGMP standards such as PIC/S/ ICH covering all regulatory guidelines; USFDA, WHO, MHRA, MCC, PMDA, GCC, SFDA etc.

Dr. Wasif delivered lectures in large International workshops & also served as conference moderator several times. Dr. Wasif is a certified "Lead Auditor" and conducted more than 100 audits of Pharmaceutical plants as well as manufacturing sites of API including many USFDA certified sites located in USA, Europe and other parts of world. Dr. Wasif has been "Examiner for PhD" several times & provided services as technical expert for journal of pharmaceutical sciences. He also appointed “Advisor/subject matter expert” on Pharmaceutical Aspects by International organizations. Dr. Wasif started his career as Teacher for Postgraduate classes in University. He has been affiliated with many leading international forums such as: Royal Society of Chemistry, American Chemical Society, New York Academy of Sciences etc.

Dr. Wasif is married with three children