Opportunity to help provide exceptional support across all facets of HR operations for pharmaceutical company.
Job Detail
Job Description
Responsibilities:
- Create and maintain documentation: The Documentation Specialist is responsible for creating, reviewing, and updating documents related to drug development and production processes, including Standard Operating Procedures (SOPs), batch records, protocols, and reports.
- Ensure compliance with regulations: The Documentation Specialist ensures that all documentation is compliant with regulatory requirements and industry standards, including Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
- Manage document control: The Documentation Specialist manages the document control system, including document creation, revision, distribution, and archiving.
- Collaborate with cross-functional teams: The Documentation Specialist collaborates with cross-functional teams, including Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs, to ensure that documentation is accurate and up-to-date.
- Provide training on documentation procedures: The Documentation Specialist provides training on documentation procedures to ensure that all employees follow proper documentation practices.
- Ensure accuracy and completeness of documentation: The Documentation Specialist ensures the accuracy and completeness of all documentation by reviewing documents for errors, omissions, and inconsistencies.
- Manage document change control: The Documentation Specialist manages document change control by ensuring that all changes to documents are properly documented, reviewed, and approved.
- Maintain document storage and retrieval systems: The Documentation Specialist maintains document storage and retrieval systems, ensuring that documents are easily accessible and properly organized.
- Perform document audits: The Documentation Specialist performs document audits to ensure that all documentation is complete, accurate, and up-to-date.
- Continuously improve documentation processes: The Documentation Specialist continuously improves documentation processes by identifying areas for improvement and implementing best practices to enhance the efficiency and effectiveness of document management.
Qualifications:
- Bachelor in a Science related field preferred
- Demonstrated organizational skills and ability to manage multiple tasks at once, drive execution and meet critical deadlines.
- Strong communication skills, both verbally and in writing
- Strong interpersonal skills and ability to train.
- Extremely proficient with MS Office products
- Strong computer skills, including SharePoint and database tools.
- Ability to quickly learn new systems and procedures.
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