Technical Manager/Regulatory Affairs
Riyadh Pharma
مجموع سنوات الخبرة :21 years, 4 أشهر
Contributing to creating and implementing best practices to support the designing processes.
Determining the design requirements and developing accordingly to meet/exceed the customer’s specifications.
Conceptualizing new designs and design revisions. Embracing and championing continuous improvement.
Improve reliability performance to reduce or eliminate issues within the manufacturing units.
Brainstorming and implementing innovative strategies to restructure the factory operations.
Uncovering and securing the business improvement opportunities within the organization.
Held responsible for plant production performance, meeting safety standards quality levels, and maintaining planned activities' orderly and productive operation. Ensuring the target productivity level was achieved daily.
Undertaking continuous training and development for enhancement with the human capital.
Planning and executing the root cause analysis and resolving problems.
Meticulously leading the key projects with R&D to support business goals.
Developing research programs incorporating current developments to improve existing manufacturing.
Comprehending the client's expectations on to-be manufactured products.
Determining and implementing the improved technologies used by suppliers, competitors, and customers.
Adopting new technologies and manufacturing processes within the company.
Overseeing the team metrics and objectives while ensuring the meeting of goals.
Entrusting with the overall accountability of assessing the effectiveness of department's plans, projects, and employees' performance through KPI (Key Performance Indicator) and applying the analysis data for more effective future planning.
Maintaining the highest standards of product quality and safety through surveillance programs such as third-party audits, supplier data analysis programs, and other best-in-class approaches.
Overseeing and assisting in the development of CTD 3.2. P1, P3 & P7 and rendering technical assistance when required.
Optimizing employee performance and skill development by recommending training tools
Shouldered with the overall accountability of implementing the transfer technology for various departments.
Assisted and backed the manufacturing and business objectives by driving the R&D, production, and planning departments.
Managed the technology transfer of the licensor's products:
Analyzed the improved technologies used by suppliers & competitors and adopted the same for better efficiency.
Carried out the end-to-end review of know-how dossier & started technology transfer in production scale for (Merck, Abbott, ICN Pharmaceuticals, Janssen Cilag, Norgine, Meda Pharma and Louis Widmer), by Research, design, and evaluating materials, assemblies, processes, and equipment to suit our factory machines and demands.
Facilitated the production processes by examining and formulating the MF, PDR, Data Sheet, and BMR
Maintained oversight on first three commercial batches (validation)
Timely carried out and completed the production troubleshooting (liquid, sterile & solids)
Adopted the economic methods to revamp the production manufacturing process for high quality.
Enhanced the economic value of the products by recommending better and more cost-effective raw materials.
Optimized the outputs by evaluating and modifying the machine's behaviour.
Served as an integral member of factory White Paper Committee.
Actively performed the troubleshooting of production batches (solid, liquid & sterile dosage forms).
Contributed to setting up the formulae and batch formulae in the ERP system
Conceptualized and steered the department quarter and yearly projects.
Managed and piloted the technology Method transfer for production.
Maintained oversight, and examined the know-how dossier & started technology transfer on a lab-scale
Dexterously steered the (Merck, Abbott, ICN Pharmaceuticals, Janssen Cilag & Norgine).
Oversaw and developed the in-house formula.
Devised the trials for both know-how and In-House formulae.
Contributed to developing and evaluating the MF, PDR, Data Sheet, BMR & BPRs for trials
Handled the core accountability of characterization and pilot batches.
Monitored and administered the first three commercial batches (validation).
Pioneered efforts in product development.
Carried out and completed troubleshooting for production batches (solid, liquid & sterile dosage forms).
Linked the Riyadh pharma item codes creator in ERP.
Played an integral role in formulating the drugs and designing the formulas.
Steered and spearheaded the manufacturing of solid, sterile, and liquid-solid forms.
Built the drug master formula.
Ensured consistency in pilot drug manufacturing by developing and reviewing the ordering of required materials.
Maintained robust intra-department coordination
Implemented new production, safety, and security strategies, which resulted in higher production output for the night shift system. Managed the authorization of personnel in the factory premises during the night shift.
Outlined and detailed the system enhancement specifications.
Facilitated the communication between the management and the employee by formulating and implementing the management procedures & reports
Implemented the diverse procedures and strengthened the communication with the employees, resulting in augmented productivity of the night shift
Reviewed and reconciled the packaging to eliminate the possibilities and outcomes of packaging errors and short & excess.
Actively involved in preparing the batch packaging record.
Managed various functions, including packaging area, output, employees, planning & market requirements within deadline.
Augmented the output by establishing and enabling the new packaging system
Served as an in-charge of various functions, including granulation, drying and blending, compression and coating.
Handled the core accountability of solid form manufacturing.
Specialists in drug design, manufacturing and development the process