Documentation &

- Review

- Preparation, review, issuance, and control of Standard Operating Procedures (SOPs) and Standard Test Procedures (STPs).

- Preparation and review of Method Development Protocols and Reports.

- Preparation and review of Method Validation Protocols, Reports, and Analytical Validation Documentation as per ICH and regulatory requirements.

- Compilation, review, and archival of analytical documents in compliance with GLP, GMP, and Data Integrity requirements.

- Ensure proper documentation practices and maintenance of laboratory records.

Analytical Data Review

- Review of routine analysis data generated during method development, method validation, and product testing.

- Review of stability study analytical data and reports.

- Verification of chromatographic data, calculations, and compliance with approved procedures.

- Ensure completeness, accuracy, and traceability of analytical records.

Working Standard &

- Instrument Management

- Preparation, qualification, and maintenance of Working Standards and Reference Standards records.

- Perform and document daily instrument verification checks.

- Monitor and maintain instrument calibration schedules and coordinate periodic calibration activities.

- Maintain records related to equipment qualification, calibration, and preventive maintenance.

Record Management

- Maintain impurity standards inventory and qualification records.

- Maintain calibration records, logbooks, worksheets, and laboratory registers.





- Ensure proper documentation and tracking of analytical standards, reagents, and reference materials.

- Support internal and external audits by providing required documentation and records.

Compliance &

- Quality Systems

- Ensure compliance with GLP, GMP, Data Integrity, and Regulatory Guidelines.

- Support investigations related to OOS, OOT, deviations, and CAPA documentation.

- Participate in continuous improvement initiatives related to documentation and laboratory quality systems.

- Ensure readiness for regulatory inspections and customer audits.

Required Skills &

- Competencies

- Robust knowledge of GLP, GMP, Data Integrity (ALCOA+), and pharmaceutical documentation practices.

- Hands-on experience in preparation and review of analytical documents.

- Understanding of ICH Guidelines, Method Development, and Method Validation.

- Knowledge of analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, etc.

- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

- Excellent documentation, reviewing, and communication skills.

- Strong attention to detail and organizational abilities.

Preferred Experience

- Experience in Analytical R&D;/Quality Control documentation activities in a pharmaceutical company.

- Exposure to regulatory requirements of USFDA, MHRA, EU GMP, WHO, and other international agencies.

- Experience handling audit documentation and laboratory quality systems.

📌 Officer/ Senior Officer - R&D (Indore)
🏢 gufic biosciences
📍 Indore