Technical Reviewer – Validation
POSITION SUMMARY
The Validation Technical Reviewer is responsible for reviewing a variety of documents and records maintained and generated by the Validation department within Piramal Pharma Solutions – Lexington. The primary purpose of the position is to provide technical and cGMP compliance review of documents and records generated by the Validation department.
PRIMARY RESPONSIBILITIES
•Perform timely technical and quality-based review of documents/records to ensure accuracy, completeness, and compliance with global cGMP requirements, applicable SOPs, client agreements, and industry standards. This includes ensuring adequate corrections are made to the documents and any events are escalated to the appropriate level of investigation, if not previous identified.
•Perform follow up activities for document/protocol closure, including document requests and compilation, review of event reports, and assisting with document revisions as appropriate.
•Design and implement a data collection and trending process for errors observed during document/record review and providing feedback to Validation management to assist with continuous improvement initiatives.
•Assist with Validation-related data integrity initiatives.
•Assist with establishing protocol templates that utilize user-centered design concepts.
•Assist with the development of SOPs associated with new and existing validated processes, systems, and the overall requirements of validation concepts and requirements, including data review and maintenance requirements.
•Continuously audit/monitor documentation and reviewer feedback to detect undesirable trends or opportunities for improvements related to quality and/or efficiency.
•Assist with the observation and/or execution of protocol activities, as appropriate for experience and training level. Observations may be used as part of the continuous improvement process associated with protocol and SOP development.
•Assist in training program development related to validation activities and concepts for both Validation personnel and other site departments.
•Assist with internal audits (self-inspection) activities, as appropriate to experience and training level.
Requirements:
QUALIFICATIONS/REQUIREMENTS
Bachelor’s degree with concentration in engineering, science, or quality required.
Three (3) years of experience in cGMP document review is required; Quality Assurance (QA) experience preferred.
Previous experience with validation activities and change control (especially as a reviewer) is desired.
Familiarity with global cGMP and validation concepts a plus.
Proficiency with Microsoft Office suite (primarily Word and Excel) required.
Self-directed and able to manage priorities against assigned timelines.
