This role is responsible for creating, reviewing, and maintaining technical
documentation related to quality control processes and activities in compliance
with established standards and regulatory requirements within a global
pharmaceutical manufacturing workplace. The incumbent ensures that all quality
control documentation accurately reflects analytical procedures, testing
methodologies, and quality standards. The position identifies documentation gaps
and inconsistencies, and takes proactive measures to improve the accuracy and
completeness of quality control records. It applies knowledge of quality
management systems, regulatory frameworks, and technical writing standards to
produce clear and compliant documentation. The role supports the definition and
specification of activities, processes, and standards to fulfill quality
requirements for pharmaceutical products and services. It contributes to the
development and maintenance of standard operating procedures, test methods, and
quality control protocols. The position reports documentation deviations and
non-conformances to the appropriate quality stakeholders. It supports the
organization's commitment to maintaining a robust quality documentation system
that underpins regulatory compliance and product quality.
Essential Functions:
* Create, review, and maintain technical documentation for quality control
processes including standard operating procedures, test methods, and quality
control protocols
* Provide QC documentation support function for US sites
* Responsibility for ensuring US FDA‑compliant, inspection‑ready QC
documentation
* Act as documentation reviewer and harmonization partner for US QC teams
* Supports change control and investigation‑driven documentation updates
* Ensure all quality control documentation accurately reflects analytical
procedures, testing methodologies, and established quality standards
* Identify documentation gaps and inconsistencies and implement corrective