Job
Description
Brief team/department description: The Associate, Documentation Management plays a key role in maintaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position supports integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, ensuring adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11. Principle Responsibilities: Maintain and support a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal procedures. Support the validation, integrity, and ongoing compliance of electronic quality systems, including document management platforms. Support the Documentation Management System, ensuring all controlled documents (e.g., SOPs, policies, work instructions) are accurately authored, reviewed, approved, and updated per lifecycle requirements. Oversee document lifecycle activities, ensuring all documentation meets GxP and regulatory standards. Support the development, maintenance, and delivery of a GxP training program to ensure relevant personnel remain current with quality and compliance standards. Participate in continuous improvement initiatives aimed at enhancing the effectiveness of quality systems and documentation processes. Assist in the management and execution of the Computer System Validation (CSV) program, ensuring alignment with 21 CFR Part 11, EU Annex 11, and applicable internal validation policies. Support internal and external audits and regulatory inspections by ensuring documentation and systems are readily accessible and compliant. Qualifications and Education Requirements Bachelor s degree in Life Sciences, Pharmacy, Quality, or a related field. 1-3 years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry. Understanding of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulations. Familiarity with electronic Document Management Systems and Computer System Validation practices. Strong attention to detail and organizational skills By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
