QA Documentation Specialist Responsibilities:Documentation Management: Create, update, and maintain accurate documentation for all system validation activities, including protocols (IQ/OQ/PQ), test scripts, reports, and other quality records.
Manage controlled documents, including SOPs, work instructions, validation records, and training materials, ensuring they are up-to-date and in compliance with regulatory standards.
Ensure that all documentation is traceable, auditable, and meets the required standards for FDA, EMA, and other regulatory bodies.
Audit and Inspection Preparation: Prepare and organize documentation for internal and external audits, including FDA inspections and other regulatory reviews.
Ensure that all system documentation is easily accessible and in compliance with document control policies and regulatory requirements.
Serve as a key contact during audits and inspections, presenting documents, records, and reports as required by auditors.
SOP and Policy Development: Collaborate with quality assurance, IT, and regulatory teams to draft, revise, and manage standard operating procedures (SOPs) related to system validation, testing, and documentation control.
Ensure all documentation practices meet company policies, GxP, GMP, and industry best practices, and continuously improve document control processes.
Training and Communication: Provide training to system users and quality teams on GxP-related documentation practices and software system requirements.
Communicate updates and changes in documentation requirements or regulatory expectations to stakeholders.
Risk Management and Continuous Improvement:Risk Assessment: Participate in risk assessments (e.g., FMEA) for system implementation, changes, and deviations to identify potential risks and ensure compliance with GxP.
Recommend mitigation strategies to minimize risks and improve system validation and documentation processes.
Process Improvement: Identify opportunities for improving QA and documentation processes to enhance compliance, efficiency, and accuracy.
Implement and support initiatives for automating documentation management and validation processes.
Qualifications:Education: Bachelor's degree in Computer Science, Information Systems, Life Sciences, or related field (or equivalent experience).
Experience: Minimum 3-5 years of experience in Quality Assurance, System Validation, and Documentation Management within the pharmaceutical, biotechnology, or life sciences industries.
In-depth knowledge of GxP, GMP, GAMP 5, and FDA 21 CFR Part 11 regulatory requirements.
Experience in system validation and testing, as well as document control and management in a highly regulated environment.
Certifications: Relevant certifications in Quality Assurance (e.g., CQA, CQE) or Computerized Systems Validation (e.g., CSV), and experience with document management systems are preferred.
Skills & Competencies:Strong knowledge of computerized system validation (CSV), GxP guidelines, and document control best practices.
Proficiency in validation testing methodologies and documentation tools (e.g., Veeva, MasterControl, SharePoint).
Exceptional organizational skills and attention to detail, especially regarding documentation accuracy.
Strong communication and collaboration skills, with the ability to work with cross-functional teams.
Problem-solving and analytical thinking, with a focus on compliance and continuous improvement.
Ability to manage multiple priorities and work in a fast-paced, regulated environment.
Preferred Experience:Experience with document management systems (DMS) and electronic quality management systems (eQMS).
Familiarity with systems like ERP, LIMS, MES, and laboratory software in a pharmaceutical or biotech setting.
Experience with audit preparation and regulatory inspections in a highly regulated industry.
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