Documentation Quality Aassucrance

1 week ago

Dera Bassi, India Job Provider Baddi Full time

**Position Overview**:
As a Documentation Quality Assurance Executive within the Research and Development (R&D) department, you will play a pivotal role in ensuring the accuracy, completeness, and compliance of all documentation related to research and development activities. You will collaborate closely with R&D teams to establish and maintain robust documentation practices in accordance with regulatory standards and company policies.

**Key Responsibilities**:

- **Document Review and Approval**:

- Review and approve various types of documentation, including but not limited to research protocols, experimental procedures, technical reports, and data summaries.
- Ensure that all documentation meets regulatory requirements, industry standards, and internal quality standards.
- **Documentation Compliance**:

- Develop and maintain documentation templates, formats, and standards to ensure consistency and compliance across all R&D projects.
- Monitor changes in regulatory requirements and update documentation processes accordingly to ensure ongoing compliance.
- **Quality Assurance Processes**:

- Implement and oversee quality assurance processes for document creation, review, approval, and archiving.
- Conduct periodic audits of documentation to identify areas for improvement and ensure adherence to established standards.
- **Cross-functional Collaboration**:

- Collaborate closely with R&D teams, including scientists, engineers, and technicians, to understand documentation needs and provide guidance on best practices.
- Liaise with other departments, such as Regulatory Affairs and Quality Assurance, to ensure alignment on documentation requirements and standards.
- **Training and Development**:

- Provide training and support to R&D staff on documentation procedures, quality standards, and regulatory requirements.
- Promote a culture of documentation excellence by fostering awareness and accountability among team members.
- **Continuous Improvement**:

- Identify opportunities for process optimization and efficiency gains within the documentation management system.
- Implement corrective and preventive actions to address documentation errors, deviations, and non-conformities.

**Qualifications**:

- Bachelor's degree in a scientific or Pharma
- Proven experience in documentation management, quality assurance, or regulatory affairs within the API industry
- Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH) and quality standards (e.g., GMP, GLP, GCP) applicable to R&D documentation.
- Excellent attention to detail and analytical skills, with the ability to review complex technical documents for accuracy and compliance.

Pay: ₹75,000.00 - ₹95,000.00 per month

**Benefits**:

- Food provided
- Health insurance
- Paid sick time
- Paid time off

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Experience**:

- r&d documentation: 10 years (required)

Work Location: In person

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