Job Description

This role is responsible for managing and maintaining documentation within a pharmaceutical manufacturing environment, ensuring the accuracy, completeness, and compliance of batch records, standard operating procedures, and other controlled documents in accordance with current Good Manufacturing Practices. It performs a range of tasks related to the documentation and record-keeping functions of the manufacturing operation, supporting regulatory compliance and audit readiness. The position operates within the document control cell, applying knowledge of GMP documentation requirements and pharmaceutical manufacturing processes to ensure the integrity of all controlled documents. It handles the review, issuance, and archiving of batch manufacturing records and other GMP documents in compliance with established procedures. The role maintains cleanliness and organization of the documentation area and ensures that all records are stored and retrieved in accordance with GMP standards. It performs standard operating procedures to meet current Good Manufacturing Practices and maintains records as required. The position contributes to process improvement initiatives and supports the development of solutions to enhance documentation quality, accuracy, and efficiency. All activities are performed in compliance with regulatory requirements and organizational quality standards.

Essential Functions:

• Manage and maintain batch manufacturing records, standard operating procedures, and other controlled documents in compliance with GMP requirements
• Review, issue, and archive batch records and GMP documents in accordance with established document control procedures
• Ensure the accuracy, completeness, and traceability of all controlled documents within the manufacturing documentation system
• Maintain cleanliness and organization of the documentation area and ensure records are stored and retrieved in compliance with GMP standards
• Complete batch documentation records accurately and in a timely manner as required by GMP standards
• Identify and escalate documentation errors, deviations, or quality concerns to the supervisor promptly
• Contribute to the development and review of standard operating procedures for documentation control activities
• Participate in process improvement initiatives to enhance documentation quality, accuracy, and efficiency

Additional Responsibilities:

Education:

• B. Pharm - Required
• M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: