Azim Arshi

Responsible for Monrol UAE, (Eczacibasi-Monrol Nuclear Products) Dubai Injectable/Sterile Plant operation, Planning, Technical operations, Purchases and Compliance.

Responsible for all regulatory activities, Ministry of Health & Prevention (MOH) & Federal Authority for Nuclear Regulation (FANR) activities.

Management of Formulation Injectable/Sterile production activities to achieve the overall company business goal and ensure all operations meet cGMP & FANR requirements
 
Responsibilities:

 Management of production activities.
 Supervise plant operations so that all cGMP and FANR requirements are met.
 Integrate the available facilities and the man powers.
 Communicate with R&D to ensure the process is smoothly transferred from Lab to production proceeds smoothly.
 Evaluate capacity expansion and any additional facilities that may be needed to respond to production planning requirement.
 Continuously improving GMP plant operations, management and overall production efficiency.
 Manage operations budget to ensure minimal production cost and optimal product quality.
 Review production processes and procedure to ensure they operate at highest possible efficiency.
 Collaborate with health/safety managers to develop and implement safety policies for general plant operations.
 Oversee the hiring and training of operations personnel to ensure a capable workforce.
 Carry out research to discover ways of improving on existing operational processes.
 Liaise with purchasing managers to develop and improve supplier relationship.
 Conduct employee performance appraisals to identify areas of limitation in order to provide coaching and guidance.
 Delegate and assign work tasks to production staff to achieve set manufacturing targets.
 Optimize production process by eliminating wastes and other constraints to improve work efficiency.
 Oversee the long-term planning and initiatives geared towards enhanced operations.

Plan and conduct scientific experiments to create prototype products.
Develop experimental programs and work plan and schedule to meet performance objectives.
Identify complex problems and offer effective solutions through development or modification of test methodology.
Review test results in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals.
Attend and present updates at the R&D meetings.
Provide technical and documentation support to the project management team.
Participate in meetings with project sponsors as required.
Record accurate and complete experimental methods and results.
Perform and document all the experiments and compile data for discussion
Review patents and literature to identify the best formulation strategies with the head of the department.
Prepare the development report.
Issue requisitions for analytical development testing Requirements.
Possess strong Formulation knowledge, Trouble shooting, problem solving & organizational abilities. Possess a flexible with an ability to work independently as well as part of a multidisciplinary team.
Ensure strict compliance to the Company’s policies on Quality, Safety, Health and Environment.
Ensure confidentiality and safe keeping of the product and departmental procedures are preserved and kept current.
Sound knowledge and understanding of pharmaceutical products/processes and GMP /QbD requirements.
Excellent analytical root cause and problem solving related to formulation, packaging and stability issues and reasoning skills.

Expertise in literature survey for the project, guidelines and updating the current developments in formulations & formulation Strategy (Trial batches, stability batches).

Responsible for formulation development, process development, technology transfer, scale-up and manufacturing support.

Entrusted with the task of troubleshooting & investigation on daily basis.

Accountable for planning the developmental activities on daily basis.

Reviewing research literature on various useful sites which give important information about the drug before and during Method Development.

Ensuring that documentation is done as per the departmental standard operating procedures (SOP’s) & regulatory guidelines.

Detailed survey of ICH guidelines for solid oral dosage form.

Expertise in manufacturing operations of various dosage forms (Parenteral, Oral Solid dosage forms, Liquids, Semi Solids).

Write, edit, update, and maintain GMP-related SOP’s, Master process, specifications, Batch manufacturing records and process validation protocols.

Asst. Officer, Production (pharmacist)