What are the responsibilities and job description for the Pharmaceutical Documentation Specialist position at Technical Source?
Job Description
Job Description
Technical Source is seeking a Documentation Specialist to support validation and process engineering efforts in a pharmaceutical manufacturing environment. This role involves managing and organizing critical documentation, ensuring compliance with GMP and regulatory requirements, and providing administrative support to technical teams. The ideal candidate will have exceptional attention to detail, strong organizational skills, and familiarity with regulated manufacturing processes.
Key Responsibilities :
- Create, review, and maintain accurate documentation related to validation protocols, reports, process changes, and SOPs.
- Ensure all documents meet GMP, FDA, and other regulatory standards, maintaining audit readiness at all times.
- Work closely with validation and process engineering teams to gather and organize technical data, ensuring timely and accurate documentation.
- Perform detailed reviews of documents to identify discrepancies, errors, or missing information.
- Assist in developing and updating training materials for process and validation procedures.
- Accurately input and manage data in documentation control systems or databases.
- Provide administrative support for validation and process engineering projects, including tracking deliverables and timelines.
- Identify opportunities to streamline documentation processes and implement best practices.
Qualifications :
