Documentation officer

Work Schedule

Environmental Conditions

Job Description

Job Responsibilities

• Coordinate the batch record review process to ensure strict compliance with regulatory and company standards.
• Collaborate with cross-functional teams to identify and implement standard methodologies for batch records.
• Conduct detailed reviews and audits of batch records to identify and resolve any discrepancies.
• Train and mentor team members to ensure detailed execution of batch record reviews.
• Develop and maintain Standard Operating Procedures (SOPs) related to batch record review.
• Ensure timely and accurate documentation of all batch record activities.
• Assist in the preparation for and participation in regulatory inspections and audits.
• Lead initiatives to continuously improve the efficiency and effectiveness of the batch record review process.

Job Requirements

• Strong understanding of regulatory requirements and compliance standards.
• Excellent attention to detail and ability to conduct thorough audits.
• Outstanding communication and collaboration skills.
• Ability to train and mentor team members effectively.
• Ambitious and proactive in identifying and implementing process improvements.