Formulation Development, RA, Production
Resume:
Mohammed Naseem Ibrahim
P.O.Box – ******, ICAD – 1, Abudhabi, U.A.E
Email: ******@*****.*** Mob: 009***********
MOH UAE Certified ‘industrial pharmacist’ having experience of 4+ years i n Pharmaceutical R&D
Formulation, Regulatory affairs and Manufacturing area. To be in a position, where I can utilize my best
knowledge and experienced skills in my interest area, for meeting objectives and targets of the stab le
organization.
Key exposured area’s
Formulation development of Solid orals, Liquid orals, Semisolid & IV Solution.
Result oriented research
Stability study design, batch preparation, review and interpretation.
Troubleshooting and redesigning of the manufacturing methodology.
Strong relative resourcing
Preparation and review of PDR, MFR and BOM.
Documentation control
Performance of Pilot scale up, optimization and technology transfer.
Quick learning
Preparation and review of p harmaceutical quality assurance documentation.
Good communication
Preparation and review of regulatory documents for GCC & MENA region.
Team management
Preparation of Pharmaceutical Registration Modules of 1 to 5.
Planning and coordination
Planning, production and effective utilization of plant facility.
Educational credentials
M aster of pharmacy with specialization Pharmaceutics Dr. M.G.R. Medical University, India.
Bachelor of Pharmacy from University of Calicut, Kerala, India.
Schooling at Chennamangaloor Higher Secondary School, Calicut, Kerala, India.
Projects summary
Preliminary Phytochemical, Antibacterial, Antioxidant Studies on Herbal Formulation.
Novel in situ gel system for Gatifloxacin sesquihydrate ocular drug delivery.
Career Highlights
W ellpharma MS, Abu Dhabi Production Head since Apr. 2013
Reporting to: Technical manager
Key roles:
Plan and Schedule the manufacturing activity of IV solution as per planning requirements.
Effective utilization and application of facility and personnel to meet objective.
Coordinate, lead and train the manufacturing personnel.
Responsible for any new product development, manufacturing activity and maintenance follow up.
Responsible for the quality of process and for regulatory compliance of production area.
Identify and request for new product tools, raw materials, packaging materials etc.
Vendor generation, supplier audits and purchase follow-ups.
Troubleshooting and reprocessing of production batches having any deviation.
Preparation and Review of change control request.
Coordinate with the adjacent department to fulfill the activities in time frame.
Highlights;
Part of the foundation staff of new pharmaceutical project, involved in all the activity.
Faced and successfully completed the validation, regulatory approvals of new facility.
Developed more than 8 products and successfully registered in the region, 10 are in pipe line.
W ellpharma MS, Abu Dhabi Production Officer Oct. 12 - Apr. 2013
Reporting to: Production manager
Key roles:
Follow the schedule of the manufacturing activity of IV solution as per planning requirements.
Effective utilization and application of facility and personnel to meet objective.
Responsible for the quality of process and for regulatory compliance of production area.
Preparation of change control request.
Coordinate with the adjacent department to fulfill the activities in time frame.
Highlights;
Part of the foundation staff of new pharmaceutical project, involved in all the activity.
Faced and successfully completed the validation, regulatory approvals of new facility.
Medpharma Pharm., Sharjah Research Pharmacist Sept. 10 – Sept. 12
Reporting to: R&D and RA Manager
Key roles:
Research activities:
Plan and Schedule the development activity of new product as per organization interest.
Identify and request for new product tools, raw materials, packaging materials etc.
Identify and conduct the preformulation study and scale up batch of each formulation.
Design stability study protocol, review and evaluate the stability data.
Troubleshooting and reprocessing of production batches having any deviation.
Preparation and Review of change control request.
Regulatory a ffairs activities:
Preparation of registration dossier for MENA and GCC countries.
Prepare the renewal/ minor variation file for existing products.
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Coordinate with the adjacent department to fulfill the activities in time frame.
Reply to regulatory agencies queries regarding technical matters.
Highlights;
8 new products are developed, registered successfully to GCC market.
7 products scale up and process validation is performed and registered.
3 products are scale up and process validation completed and under registration process.
Completed 12 Registration dossiers for GCC and 10 registration dossiers for MENA region.
Medpharma, Sharjah Production QAIPC officer May 10 – Sept. 10
Reporting to: Quality Manager
Key roles:
Maintains awareness of manufacturing activities by routine direct observation and implementation of
quality perspective on routine operations.
Participates in the development of standard work practices, CAPA, improvement initiatives to ensure
high and consistent level of quality is maintained across shifts.
Preparation, review and implementation of SOP’s and batch record in an efficient and timely manner.
Review and evaluate QC results for raw materials, intermediates, and finished product and Performs
product release/rejection function for in-process, bulk finished product materials, and in process
packaged product.
Support and participate in compliance– critical efforts including change controls and validation processes
related to value stream and Assure that any observations/non-conformances are properly investigated and
explained.
Highlights;
Handling and replying of technical queries regarding production process of different formulation.
Investigation and reporting of process related to issues of orals and semisolids.
Involvement in process validation and revalidation activities.
Bioplus, Banglore Industrial pharmacist trainee Aug. 07 – Sept. 07
Reporting to: Plant Manager
Key roles and Highlights:
Basic understanding of manufacturing process and all other related activity of pharmaceutical plant.
Understanding of Quality control techniques and equipment operations.
Detailed study of the process protocols and modification proposal if any.
Trained and evaluated under highly experienced personalities.
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Certified Training and Workshop attended
National level symposium on “Newer Technology in Pharmaceutical Education and Industry”, Madras
medical college, Chennai.2009.
National level seminar on “Stereo chemical adventures in the synthesis of challenging Drug Molecules” PSG
College of pharmacy, Coimbatore.2009.
Scientific seminar on “NMR spectroscopy”, J.K.K Nataraja college of pharmacy, Tamilnadu.2009
National level seminar on “Recent trends in Pharmaceutical Sciences and Education”, Al Shifa College of
pharmacy, Kerala.2008.
Scientific seminar on “Current trends in pharmaceutical research – A survey yesterday, today and
tomorrow”, J.K.K Nataraja college of pharmacy, Tamilnadu.2008
State level seminar on “Bio-Herbal Applications in Pharmacy”, Cherraan’s college of Pharmacy, Coimbatore,
Tamil Nadu, India,2007.
State level seminar on “Good manufacturing practice”, National College of Pharmacy Calicut, Kerala.2007.
International-E-Symposium on Pharmaceutical Engineering, Bharathi Dasan University, Tiruchirapall y, Tamil
Nadu, India, 2006.
Technical profile
Familiar with all the Microsoft OS and expert in MS office, Adobe Photoshop, Adobe acrobat.
Experienced in Windows software management and service.
Languages Known: English, Hindi, Tamil, Arabic and Malayalam.
Personal profiles
th
Date of Birth : 07 May 1986
Marital Status : married
Citizenship : Indian
Passport Number : L 3410027
UAE driving license number: 498486
Reference : up on request
Declaration
I do hereby declare that the particulars given above are correct to the best of my knowledge and
belief.
Sd/-
Date: Mohammed Naseem Ibrahim
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