Description:
We are recruiting a highly motivated Digital GMP Forms Specialist to support the transition from paper-based GMP fillable forms and logbooks to digital, audit-trailed records. This role is pivotal in driving compliance, data integrity, and workflow automation within regulated environments. The successful candidate will work closely with cross-functional teams to ensure seamless digitization of critical documentation.
Responsibilities
- Digitize GMP forms and logbooks, ensuring accurate version control and metadata tagging for compliance.
- Apply advanced spreadsheet techniques (e.g., formulas, conditional formatting, data validation) to support automation and data integrity.
- Collaborate with internal teams to understand form requirements and workflows.
- Maintain a central repository of common formulae and conditional formats.
- Review and test peers' work to ensure proper setup and functionality.
- Develop and maintain dashboards to monitor performance and digitization progress.
- Query relational databases to perform data analytics and generate insights.
- Train internal users on form usage and digital workflows as needed.
The Person
The ideal candidate will be a proactive and detail-oriented professional with a passion for technology and process improvement.
Experience
- Proficiency in Microsoft Excel or equivalent spreadsheet tools.
- Experience formatting Word documents (tables, fonts, pagination, etc.).
- Strong self-discipline and motivation to work independently on piece-work tasks.
- Excellent attention to detail and ability to adhere to SOPs and compliance rules.
- Clear and effective communication skills for training and documentation.
- Professional-level English speaker and writer.
Desirable Criteria
- Prior experience in pharmaceutical, GMP, or GxP-regulated environments.
- Familiarity with digital document systems or form automation platforms.
- Experience in digitization projects or data analytics.
- Multi-lingual capabilities (e.g., Spanish, Italian, Japanese, Chinese).
- Ability to write simple data queries (SQL, Python, R).