Job Description

Job Description Job Summary: We are looking for a meticulous and experienced Senior Document Control Specialist to join our team. The ideal candidate will have a strong background in document management within the pharmaceutical industry, ensuring that all documentation complies with regulatory standards and supports our quality assurance processes. Key Responsibilities: Develop, implement, and maintain document control systems and procedures in a paper-based QMS. Manage the creation, review, approval, distribution, and archiving of controlled documents. Ensure all documentation complies with GMP (Good Manufacturing Practices), FDA regulations, and other relevant standards. Coordinate with cross-functional teams to ensure timely and accurate documentation. Conduct regular audits of document control processes and systems to ensure compliance and identify areas for improvement. Train and support staff on document control procedures and systems. Manage document change control processes, including tracking and implementing changes. Prepare and present documentation reports to senior management. Qualifications: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or related field. Advanced degree preferred. Minimum of 5–7 years of experience in document control within the pharmaceutical industry. In-depth knowledge of GMP, FDA regulations, and other relevant quality standards. Strong organizational and project management skills. Excellent attention to detail and accuracy. Proficient in document management systems (DMS) and electronic documentation systems. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Preferred Skills: Certification in document control or quality assurance (e.g., ISO 9001 Lead Auditor) is a plus. Experience with batch records, validation protocols, and other quality-related documents. Familiarity with international regulatory requirements (e.g., EMA, ICH guidelines). Experience with electronic document management systems (EDMS). Term: ~6-month initial term, extension likely, conversion to FTE possible

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