Senior Documentation Analyst

SVAK Life Sciences

South Carolina

On-site

USD 3,105 - 8,280

Full time

14 days+

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Job summary

SVAK Life Sciences in Hyderabad seeks a documentation specialist to develop, implement, and maintain documentation procedures for R&D projects, ensuring accuracy and regulatory compliance.

You will review technical documents, manage records, and support cross-functional teams with formatting, reports, and external submissions, while upholding FDA/ISO standards and internal policies.

Qualifications

Experience with documentation procedures and regulatory compliance.
Proven ability to manage records and ensure accuracy.
Strong written and verbal communication, detail-oriented.

Responsibilities

Develop, implement, and maintain documentation procedures and standards for R&D projects.
Create, review, and update technical documents, research reports, and project records.
Ensure all documentation meets regulatory requirements and industry standards.
Organize and maintain electronic and physical document storage systems.
Manage version control to track changes and revisions in documents.
Support R&D with formatting, presentations, and external submissions.
Review documentation for accuracy, completeness, and adherence to quality standards.
Create and ensure compliance with relevant regulatory requirements (e.g., FDA, ISO) and internal policies.
Provide training and support to R&D staff on documentation procedures and best practices.

Skills

Documentation

QA processes

Regulatory requirements

Communication

Time management

Teamwork

Education

M.Sc./B.Sc. / M.Pharm / B.Pharm (Chemistry)

Job description

Strong knowledge of documentation standards, quality assurance processes, and regulatory requirements. Excellent written and verbal communication skills, with attention to detail and accuracy. Ability to work independently and as part of a team, with strong organizational and time management skills.

Responsibilities

Documentation Management: Develop, implement, and maintain documentation procedures and standards for R&D projects.
Create, review, and update technical documents, research reports, and project records.
Ensure all documentation meets regulatory requirements and industry standards.

Record Keeping

Organize and maintain electronic and physical document storage systems.
Manage version control to track changes and revisions in documents.
Ensure proper archiving of completed projects and historical data.

Collaboration And Support

Work closely with R&D teams to understand documentation needs and provide support in creating and formatting documents.
Facilitate communication between departments to ensure accuracy and consistency of information.
Assist in preparing presentations, technical papers, and reports for internal and external stakeholders.

Compliance And Quality Assurance

Review documentation for accuracy, completeness, and adherence to quality standards.
Create and ensure compliance with relevant regulatory requirements (e.g., FDA, ISO) and internal policies.

Training And Guidance

Provide training and support to R&D staff on documentation procedures and best practices.
Develop and maintain documentation guidelines and training materials.

Project Support

Assist in the preparation of documentation for grant proposals, patent applications, and other external submissions.
Support project managers by tracking documentation milestones and deadlines.

Required Educational Qualification & Relevant Experience

M. Sc. / B. Sc. / M. Pharm/ B. pharm (Chemistry) with 2 - 5 years of relevant experience Proven experience (3+ years)

At SVAK Life Sciences, our strength lies within our team who are adaptable to the growing challenges faced by the industry.

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