Documentation Specialist

Job Title:
Documentation Specialist (Batch Record Data Reviewer)

Duration: 12 Months

We are seeking an experienced Quality Documentation Specialist (Batch Record Data Reviewer) to support batch release activities within an API manufacturing environment. This role is responsible for conducting detailed reviews of batch production records and GMP documentation to ensure accuracy, completeness, compliance, and timely identification of quality issues prior to final batch release. The ideal candidate will have hands‑on experience in API manufacturing, a strong understanding of GMP documentation practices, and the ability to identify compliance risks, documentation discrepancies, and potential investigation triggers.

• Perform comprehensive reviews of batch records and manufacturing documentation
• Verify documentation completeness, accuracy, and compliance with GMP requirement
• Review production records, logbooks, and supporting documentation to ensure batch release readine
• Identify and escalation:
  Documentation errors, Missing or incomplete information, Quality events and deviations, Potential investigation triggers, Collaborate with QA, Manufacturing, QC, Technical Services, and Investigation teams to resolve documentation issues.
• Support timely closure of batch review comments and documentation discrepancies.
• Monitor and communicate recurring documentation trends, compliance risks, and process bottlenecks.
• Ensure adherence to data integrity principles and regulatory requirements.
• Support continuous improvement initiatives related to documentation quality and batch review processes.

• Hands‑on experience in API Manufacturing environments.
• Experience reviewing GMP batch records and manufacturing documentation.
• Background in QA, QC, Manufacturing Support, or GMP documentation review activities.
• Strong understanding of GMP regulations, documentation practices, and data integrity requirements.
• Knowledge of batch release processes and quality systems.
• Experience with one or more of the following systems:
  Track Wise, Eqms, MESL, IMSERP systems (preferred)

• Excellent attention to detail and strong documentation review capabilities.
• Ability to manage high‑volume record review activities efficiently.
• Strong analytical, problem‑solving, and communication skills.
• Proactive approach with a strong sense of ownership and urgency.
  
  Ability to work effectively in a cross‑functional GMP manufacturing environment.
• Experience identifying documentation trends and supporting quality improvement initiatives.