shomaila ajmal
Production Head(Manufacturing of Sterile Products)Pharmacists
Abu Dhabi
Summary of Career
1. Preparation of daily, weekly and monthly production plan according to SOP
2. Check raw materials
3. Planning and organizing production schedules
4. Organizing the repair and routine maintenance of production equipment.
5. Checks and confirms the batch processes, details including Batch no., manufacturing and expiry date
6. Checks and maintain hygiene and GMP standards in the area.
7. Ensure and maintain the availability of stock of consumable items for production related work. Prepare request for the shortage.
8. Develop and implement new processes for fewer safety incident
9. Check Production activities of equipment such as Vessels, Dryers, Compression, Manufacturing Liquid Tanks, Filling Equipment, etc. Conducts validation activities of Utilities such as HVAC, Water System, Compressed Air and Nitrogen gas.
10. Proper documentation regarding Quality (9001) Environment (14001) and OSHAS(18001) and look after as internal auditor
Experience as Production Head(Pharmacist) (Sterile Area)
17 April 2017
16 July 2019
Preparation of daily, weekly and monthly production plan according to SOP. Check raw materials as per the material issue voucher. Planning and organizing production schedules. Organizing the repair and routine maintenance of production equipment. Ensures that the Production / Production process is as per the standard procedures. Checks and confirms the batch processes, details including Batch no., manufacturing and expiry date. Checks and maintain hygiene and GMP standards in the area. Ensure and maintain the availability of stock of consumable items for production related work. Prepare request for the shortage. Performs operations according to the (BMR or MFM) and related SOPs. Checks and maintains all related logbooks and records. Approves the start-up of all activities in coordination with Quality Assurance department.
Liaising with buyers and marketing and sales staff. Develop and implement new processes for fewer safety incidents. Preparation of SOPs, raising change control, exception, process non-conformance and Material non-conformance, implementation of CAPA in QMS and preparation of related
Investigation reports. Supervising the work of junior staff and give cGMP training.
Ensure efficient collaboration and coordination between relevant departments including Quality Assurance, Distribution and Management. Check Production activities of equipment such as Vessels, Dryers, Compression, Manufacturing Liquid Tanks, Filling Equipment, etc. Conducts validation activities of Utilities such as HVAC, Water System, Compressed Air and Nitrogen gas. Involves in product hold time activities. Participates in Internal and Regulatory audits (such as MOH, GCC). Performs all activities in compliance with safety standards and SOPs. Temperature mapping Studies of Storage facilities
Experience as Senior Production Executive
20 January 2013
10 December 2016
Plan, control & review production schedule for the job Determine the human resources & material resources required
Monitor quality standards of products& standard operating procedures
Implement and enforce quality control and tracking programs to meet quality objectives Make decisions about equipment use, maintenance, modification and procurement Analyze production and quality control to detect and correct problems
Determine and implement improvements to the production process Estimate production costs. Set& manage production budgets
Expert in Process Non Sterile Dosage forms. Conducts Production activities for Process and cleaning.
Experience as Senior Quality Assurance Executive(sterile area vials,ampoules,infusion)
05 September 2011
10 December 2012
Providing facilitation/consultation to projects to implement QMS processes Should be able to understand, collect and report Project data
Provide facilitation to projects and conduct basic quality trainings Collect, analyze and report metrics data in projects
Coordinate with customer regarding project metrics data
Review and approve SOPs (Team and Site), change control documentation, validation protocols completed validation packages, IQ/OQ/PQ protocols.
Proper documentation regarding Quality (9001) Environment (14001) and OSHAS(18001) and look after as internal auditor
Experience as Production Officer
08 July 2010
28 July 2011
Monitors drugs manufacturing activities in compliance with the requirements of cGMP
Responsible for any delay during daily as well as weekly work schedule.
Performs other duties as assigned by Production Executive/ Asstt. Manager Production.
Ensures the hygienic condition of production personnel.
Checks the availability of adequate raw, packing materials, utilities,filters and machine size parts.
Responsible for materials issued from warehouse for manufacturing
Check Production activities of equipment such as Blenders,Granulation,Vessels, Dryers, Compression, Coating, Capsule Filling, Manufacturing Liquid Tanks, Filling Equipment. Performs all activities in compliance with safety standards and SOPs. Temperature mapping Studies of Storage facilities
Experience as Pharmacist
05 October 2009
27 April 2010
Prepares medications by reviewing and interpreting physician orders
Dispenses medications by compounding, packaging, and labeling pharmaceuticals
Controls medications by monitoring drug therapies; advising interventions
Maintains safe and clean working environment by complying with procedures, rules, and regulations.
Matric 10 April 2001
Science Subjects Army Public School (C.O.D) Karachi,PakistanIntermediate 04 March 2004
Pre-Medical Malir College Karachi,PakistanBachelor 03 February 2010
Pharm D.(bachelor of Science or Pharmacy) Specialist of Pharmaceutical or Pharmacy Baqai Medical University,Karachi.Pakistan