Executive, QC Technical Writer
Amneal Pharmaceuticals · Ahmedabad
Description:
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 environment. 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 measures to improve accuracy and completeness of quality records
- Apply knowledge of regulatory frameworks and technical writing standards to produce clear, compliant, and audit-ready documentation
- Support the definition and specification of activities, processes, and standards to fulfill quality requirements for pharmaceutical products
- Contribute to the development and revision of standard operating procedures and quality control protocols in alignment with GMP requirements
- Report documentation deviations and non-conformances to relevant quality stakeholders in a timely manner
- Collaborate with quality control and manufacturing teams to ensure documentation reflects current practices and regulatory expectations
- Maintain accurate and complete records of all documentation activities in compliance with GMP and GDP requirements
Additional Responsibilities:
- Prepare, review, and update QC documents including SOPs, specifications, test methods, protocols, reports, and quality records.
- Ensure documentation complies with GMP, regulatory guidelines, and internal quality systems.
- Collaborate with QC analysts, QA teams, and cross-functional departments to collect technical information and create clear documentation.
- Maintain document control processes, including version management, revisions, and archival activities.
- Initiate and evaluate the change control.
- Perform Monograph Evolution.
- Support audits and regulatory inspections by providing required documentation and records.
- Identify documentation gaps and recommend improvements to enhance compliance and efficiency.
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