Job Description

Job Title : Documentation Specialist – Validation (Aseptic Processing, IQ/OQ/PQ)

Department : Quality Assurance / Validation

Position 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 IQ/OQ/PQ 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.

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