Officer/ Senior Officer - R&D

GUFIC BIOSCIENCES LIMITED; Indore District, Pithampur; On-site; INR 600,000 - 900,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in Indore, India is seeking a Documentation & Review professional to manage SOPs, STPs, and analytical validation documentation. The role emphasizes compliance with GLP, GMP, and data integrity, with a focus on accurate record-keeping and regulatory readiness.

The candidate will review method development, validation reports, and analytical data, ensuring traceability and readiness for internal and external audits.

Qualifications

• Proficient in preparation and review of analytical documents.
• Knowledge of GLP, GMP, and data integrity requirements.
• Understanding of ICH guidelines and regulatory expectations.
• Familiarity with analytical instruments (HPLC, GC, UV-Vis, dissolution).
• Strong documentation, review, and communication skills.

Responsibilities

• Prepare, review, and control SOPs, STPs, and method docs.
• Review method development, validation, and related reports.
• Maintain laboratory records with traceable documentation.
• Support audits and regulatory inspections with compliant records.

Skills

GLP/GMP/Data Integrity

Analytical documentation

ICH Guidelines

Microsoft Office

Communication skills

Attention to detail

Organization

Tools

HPLC

GC

UV-Vis Spectrophotometer

Dissolution Apparatus

Job description

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

• Strong 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.