Objectives:

• Meet the most stringent regulatory requirements and surpass the industry standards in terms of safety, efficacy and quality of the products.

Work Methodology:

Quality Control:

• Responsible for sampling, testing and providing documented evidence that all materials and products are in compliance with predetermined specifications and are suitable for their intended use.
• Responsible for sampling, testing and providing documented evidence that all materials and products are in compliance with predetermined specifications and are suitable for their intended use.
• Equipped with the most modern analytical instruments complying with Good Laboratory Practices (GLP) which conduct the testing in accordance with the applicable pharmacopoeias monographs (BRITISH PHARMACOPEIA, US PHARMACOPEIA).
• Certified analysts:
  • Carry out raw material, packaging material and bulk and finished product analysis.
  • Review the batch documents.
  • Environmental monitoring of the plant through personnel swabs, surfaces swabs & machine swabs.

Quality Assurance:

• Encompasses all current good manufacturing practices (cGMP’s) including effective quality control (QC) as well as design and development considerations.
  • Deviation handling.
  • Corrective and preventive measures.
  • Handling of customer complaints and organizing product recalls (should they become necessary).
  • Coordinating documentation efforts, document control, finished product release.
  • Supervising qualification and validation activities.
  • Internal & external consultants: carry out quality audits and advise us on the continuous improvement of easy quality system.
  • QA Responsibilities:
    • Full compliance to Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP).
    • Continuous in-process control & monitoring.
    • Equipment, process and utilities validation.
    • Vendors auditing and approval.
    • Standard Operating Procedures.
    • Compliance to ISO 9001, 14001 & 18001 standards.
    • Continuous training and upgrading the knowledge of quality observant.
    • Internal Audit of the plant.
  • Social & Environmental Responsibilities:
  • easy places the Consumer in its focal concern through:
    • Devotion of the whole staff at various levels within the organization to quality standards.
    • The continual improvement, training, and increasing self capabilities of our employees.
    • Application of ISO Standards for Quality & Environmental Management Systems.
  • ISO 14001 (ENVIROMENTAL MANAGEMENT SYSTEM)
    • Water waste is analyzed routinely to assure its compliance with the regulatory requirements.
    • Procedures are set and implemented to assure environmental protection during waste disposal.
    • Communicates with official environmental parties.
    • Obtain environmental brochures, circulars & journals to update its knowledge.
    • Prohibiting smoking within factory site.
  • ISO 9001: 2008 (Quality MANGEMENT SYSTEM)
  • ISO 18001:2007( OCCUPTIONAL HEALTH AND SAFETY MANGEMENT SYSEM )
    • Manufacturing safe, effective, and highest quality products.
    • Implementing procedures that guard against product contamination or mix-ups.
    • Considering the employees & product safety in the design of the factory machinery usage and training programs.
  • Enforce the Safety of the Employee and Products by:
    • Sampling and Dispensing raw materials under safety cabinets designed to protect the employees and materials.
    • Manufacturing processes are performed in areas isolated completely from external environment.
    • Procedures are set and implemented to assure employee / product safety during handling and manufacturing, as employees wear safety tools during manufacturing and analyzing the product.