Description
JOB DESCRIPTION
This role is responsible for preparing, maintaining, and controlling manufacturing documentation within a regulated pharmaceutical manufacturing environment, ensuring that all batch records, standard operating procedures, and related documents are accurate, complete, and compliant with current Good Manufacturing Practices and applicable regulatory requirements. The position supports the documentation lifecycle including creation, review, revision, and archival of manufacturing documents in accordance with established document control procedures. It ensures that all manufacturing documentation accurately reflects executed processes and meets the requirements of regulatory agencies including FDA and EMA. The role collaborates with manufacturing, quality, and regulatory teams to ensure documentation integrity and compliance across all production activities. It performs reviews of completed batch records to identify discrepancies, errors, or deviations and escalates findings as required. Accurate and timely completion of documentation tasks is a core accountability of this position. The role participates in process improvement initiatives and functional team projects aimed at enhancing documentation quality, efficiency, and compliance. It operates within a highly regulated pharmaceutical environment, ensuring all documentation outputs meet defined quality and regulatory standards.
Essential Functions
- Prepare, review, and maintain manufacturing batch records, standard operating procedures, and related documentation in compliance with cGMP and regulatory requirements
- Support the documentation lifecycle including creation, revision, review, and archival of manufacturing documents in accordance with document control procedures
- Review completed batch records to identify discrepancies, errors, or deviations and escalate findings to relevant stakeholders
- Ensure all manufacturing documentation accurately reflects executed processes and meets the requirements of regulatory agencies including FDA and EMA
- Collaborate with manufacturing, quality, and regulatory teams to ensure documentation integrity and compliance across all production activities
- Maintain accurate and complete documentation records including batch record logs and document revision histories
- Ensure all documentation activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements
- Participate in process improvement projects and functional team initiatives to enhance documentation quality, efficiency, and compliance
- Support training activities related to documentation standards and cGMP requirements as required
Additional Responsibilities
QUALIFICATIONS
Education
- Bachelors Degree (BA/BS) B. Sc. - Required
- Master Degree (MS/MA) M.Sc. - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:
