Documentation Specialist (IQ, OQ, PQ)_

Job Title: Documentation Specialist - Validation (Aseptic Processing, IQOQPQ)Department: Quality Assurance ValidationPosition Overview: We are seeking a highly skilled and detail-oriented Documentation Specialist with expertise in Validation for Aseptic Processing. The ideal candidate will play a key role in the documentation and execution of validation protocols, specifically in the areas of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This position ensures that all validation documentation meets regulatory requirements and industry best practices while supporting aseptic processing systems and equipment. Key Responsibilities:Documentation Management:Develop, review, and maintain validation documents, including IQ, OQ, and PQ protocols and reports for aseptic processing systems.Ensure all validation activities comply with regulatory standards (e.g., FDA, EMA, ISO) and corporate policies.Coordinate and manage document revisions and ensure proper version control.Maintain proper documentation practices and audit trails for all validation processes and results.Validation Execution Support:Assist in planning, organizing, and executing validation activities for aseptic processing equipment and systems.Collaborate with engineering, quality assurance, and operations teams during the installation, operational, and performance qualification phases.Support the preparation and review of validation master plans, risk assessments, and validation protocols.Regulatory Compliance:Ensure all validation documentation meets the highest standards of quality and complies with regulatory and industry guidelines.Support internal and external audits related to validation documentation.Track changes and updates in regulatory requirements and ensure proper alignment with company processes.Experience:Minimum of 3-5 years of experience in documentation, validation, or quality assurance within the pharmaceutical, biotechnology, or medical device industries.Specific experience in aseptic processing, including IQOQPQ protocols, is highly preferred.Skills:Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).Proficiency in writing and reviewing technical documents, validation protocols, and reports.Experience with validation software and document management systems is a plus.Excellent attention to detail and ability to identify and address inconsistencies or discrepancies in documentation.Strong communication skills, both written and verbal, to effectively collaborate with cross-functional teams.Other Requirements:Ability to work independently and manage multiple tasks simultaneously.Strong problem-solving skills and ability to interpret complex technical information.Knowledge of risk-based validation methodologies is beneficial.

Created: 2025-02-07