Quality

Organizational Management & Resposibility

Site quality organization report directly into central quality organization directly oversees processes, standards, and decision making for quality issues at the site level. The link between the quality function and the operations function - whether at the site, regional, or business unit level - is quite varied in terms of its strength and nature.

Quality assurance is co-ordinated centrally, with quality control integrated into manufacturing in this case, over sight for quality assurance (QA) is centralized, and quality control (QA) is centralized, and quality control (QC) is handled by the manufacturing organization.

Quality functions are integrated into manufacturing but with some centralized quality co-ordination these organizations. The quality function is embedded in the manufacturing organization, but a dotted-line reporting connection to central quality ensures consistent policies and procedures across sites

Quality functions are integrated into manufacturing but with some centralized quality co-ordination these organizations. The quality function is embedded in the manufacturing organization, but a dotted-line reporting connection to central quality ensures consistent policies and procedures across sites

QUALITY DEPARTMENT HIERARCHY

The Major Responsibilities of the quality department in Medburg is to

  • To offer a quarantee that the person who is administering medicine is confident that every unit will achieve the desired effect

  • To protect users for products from possible accidental defect in the manufacture, design, storage as well as usage instructions.

  • To ensure the law is complied with to the latter.

  • To offer protection of the manufacturing organization.

Medburg's Chief Quality Officer.

The Medburg Chief Quality Officer is directly responsible to the Chief Executive Officer for defining the Medburg Quality Policy, Co-ordinating its implementation across the manufacturing companies and ensuring compliance with the related regulatory and Company requirement. The Medburg's Chief Quality Officer is the representative of the Senior Management for quality related matter.

Medburg's Quality Assurance Officer.

As Medburg gives its highest importance to the quality, one of the director himself will assist the quality officer. It is to ensure the policies and plans are implimented using companies reporting systems.

Third Line Managers in Quality Assurance.

Depending up on the companies instructions and manufacturers preferences, also based on the volume of and type of drug in production the Chief Quality Officer will decide the quality over site and integration of policies.

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