Creative professional chemist who has been consistently praised as cooperative by my subordinate, management and colleagues.
Over the course of my fourteen years of experience career, I've developed a skill set directly relevant to the pharmaceutical industry roles , including Risk management system, Formulation, Time management, Complex Problem Solving, ISO standard, Understanding of cross-cultural issues, Cost accounting, Validation and Ms Office programs.
My experience has spread over a broad spectrum of pharmaceutical industry in the veterinary and human fields for a variety of pharmaceutical dosage forms such as solid, liquid, semi-solid.
Overall, I have consistently developed quality management system abilities in every aspect of my technical coordinator role in addition to Contribution to improve productivity in many production areas , I aspire to provide exceptional and valuable addition to your
organization and I invite you to review my achievements in details.
Applied Chemistry
- Coordination between technical departments among itself and between technical department and upper management.
- Provide technical assessments for supply chain changes, highlight technical risks, and recommend the needs to support the change.
- Coordination between production and marketing heads to get delivery on time.
- Identify opportunities to develop technical capabilities within Operations sites, and Provide training to meet agreed capability targets.
- Responsible for collaboration and communication with various teams as needed
- Conduct interviews, hire, and train new technical staff as necessary
- Provide guidance and insight to upper management & report progress, including any changes made to plans and production
- Contribute to product design and establishment of requirements
- Coordination with all departments to deliver products consistently, on time and on budget
- Studying the technical problems that obstacle the work and trying to solve it in
Coordination with all company's head departments.
- following up implementation of monthly and annually plan of the technical departments previously approved in advance
- Performing periodic inspections to the company's technical departments with the head departments to verify the work performance.
- Ensuring that the quality system is implemented and followed up at all times.
- Reviewing reports of the annual review of final products in coordination with the technical committee members.
- Contribute to the preparation of technically complex responses to regulatory questions.
- Reporting to the upper management on the performance of the adopted management systems and any need for improvement
- participate in establishing quality risk management system.
-Responsible for meeting production requirements, delivering quality products to customers in a timely fashion and cost-efficient manner.
-participate in Responsibility for driving operational excellence and flawless execution in the areas of cost
reduction, discard reduction, annual productivity improvements, inventory turnover, on time delivery and lead time reduction,
-Coordinates interdepartmental activities to ensure the arrival materials within scheduled frame time.
-Monitoring raw material and finished product inventory levels to maintain proper replenishment plans.
-Responsible to ensure production output is on time and in full
-Responsible to monitor and ensure the flow of raw materials to finished product is being accomplished in the most efficient manner.
- Responsible for the overall organization and cleanliness of the production area.
- Troubleshooting any issues arising during the manufacturing process.
- -Ensures that the operation during the shifts are meeting to the objectives for quality and productivity .
-Ensures that department complies with all safety rules and procedures, as well as good housekeeping within the plant, in accordance with SOPs, Work Instructions and GMPs.
-Responsible to all production area staff including motivating, disciplining, training and maintaining appropriate documentation
-Work Closely with Maintenance and Engineering to ensure proper functioning of production equipment and to minimize downtime.
-Follow up the technical aspects of the expansion project of the factory to ensure that everything meets to cGMP requirements (layout, HVAC, machine urs, etc...).
-Development of new products.
- Managing formulation projects from laboratory to full-scale manufacture.
- Troubleshooting any issues arising during the manufacturing process.
- Analysis of current/future markets for development in participation with marketing team.
- Competitor product analysis.
- Day to day follow-up of the problems occurring in the production departments and ensure that robust and effective solutions are found.
- Source, test and approve raw materials for new and existing products.
- Liaising with suppliers as required, to evaluating the new materials to be used.
- Work to develop and improve manufacturing process.
- Designing of most appropriate, economical and feasible formula for given target product
- Assisting when required with day to day production duties.
- provide technical guidance to the technical staff as needed.
- Develop and review source documents for regulatory submissions.
- Participates in internal audits.
- Supervise quality laboratory operations and personnel
-Assist with resolution of customer complaints and questions regarding product quality.
-participate in Maintain the plant Quality Management System in compliance with outside certifications and internal quality standards.
-Support operations through in-process and product conformance testing.
-Participate in troubleshooting, technology transfers, and process improvement activities.
- Oversee activities in the production departments which involve Quality and QC Inspectors
-Create weekly and weekend QC schedules limiting overtime as much as possible.
-Review quality control standards, specifications, and procedures, and evaluate effectiveness of quality control program
- Supervise the Validation Activities.
-Provide training to the technical staff regarding new SOPs and GMPs.
- Assist in investigation of nonconformance and customer complaints
-Author or amend stability protocols, and author interim and final stability reports.
-Coordinate with Supply Chain to ensure availability of general lab supplies and reagents
-Coordinate the stability testing schedule, supervise QC analysts in the writing of stability related quality system records.
- Troubleshooting of chromatography and other related issues.
- Performing laboratory investigations for any Out-of-Trend, Out-of-Specification or Atypical results to ensure that the root cause is identified and remedial action is taken.
- Evaluation of the measurement uncertainty as well as use statistical techniques for analysis of data
- Participation in the annual program of Proficiency Testing Study (PTS) organized by the European Directorate for the Quality of Medicines (EDQM).
- Existing product evaluation and formulation modification as required.
- Designing of most appropriate, economical and feasible formula for given target product
-improve and troubleshooting problem submitted by customer from another factory (human-veterinary-cosmetic).
- Preparing samples of products for customer approval.
- Conduct analysis and experimentation on formula, for such purposes as product and process development and improvement of analytical methodologies.
-Develop standard operating procedures (SOPs).
-Conduct compatibility studies for the newly developed formulations of various dosage forms like tablets, capsules, suspensions, creams, ointments and topical solutions to study the characteristic changes, drug interaction between the API and the excipients.
Writes and reviews analytical methods, deviations, protocols, SOPs , BMR and any other technical documents.
-Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
-Provides project support for new product development which requires a close working relationship directly with Customers as well as suppliers.
- Testing stability samples by following the testing protocols and validated methods.
- Development and validation of analytical methods for new and existing products.
- Preparation of validation protocols and reports.
