Documentation Manager Job in Fabtech

Job Title: Documentation Manager

Function: Quality Assurance & Documentation

Location: Andheri, Mumbai (Head Office)

Reporting To: Assistant General Manager

Overview:

We are seeking a highly detail-oriented and experienced Documentation Manager to lead and manage documentation processes related to quality assurance, validation, compliance, and client communication. The ideal candidate will play a pivotal role in ensuring the accuracy, completeness, and regulatory alignment of all technical documentation across pharmaceutical manufacturing and injectable lines.

Qualifications & Experience:

• Education: B. Pharma / M. Pharma / B.E. / B. Tech
• Experience: 8 to 12 years in pharmaceutical manufacturing, quality assurance, and documentation management

Key Responsibilities:

Documentation & Compliance:

• Prepare and implement documentation for facilities, utilities, processes, equipment, and cleaning validation.
• Develop, review, and manage FDS, FAT, SAT, IQ, OQ, PQ, and commissioning documentation.
• Lead execution and validation of installation, operational, and performance qualification (IOPQ).
• Ensure compliance with 21 CFR Part 11 and regulatory requirements for USFDA, MHRA, ANVISA, TGA, WHO, MOHAP-UAE, etc.
• Implement and maintain documentation controls in line with ISO-QMS/EMS & OHSMS standards.

Project & Validation Oversight:

• Manage facility commissioning and installation activities for injectable lines (liquid and lyophilized).
• Validate equipment like freeze dryers, autoclaves, depyrogenation tunnels, vial filling and sealing machines, etc.
• Support SIP and cleaning validation, BMR implementation, and automation integration (PLC, SCADA, BMS).
• Understand URS and process flow diagrams; apply them to QAP creation and equipment/system validation.

Process Improvement & Quality Systems:

• Develop and standardize controlled document templates for equipment/system qualification.
• Coordinate vendor qualifications by assessing technical and manufacturing capabilities.
• Lead quality processes including change control, deviations, CAPA, and process deviation investigations.
• Compile validation batch reports, and participate in sampling and analysis activities.
• Prepare and review SOPs and work breakdown structures (WBS) for QC-related processes.
• Oversee cleanroom, HVAC, black and clean utility validation protocols and internal FAT reports.

Technical Skills & Tools:

• Strong understanding of pharmaceutical documentation requirements and regulatory audits.
• Proficient in AutoCAD and ERP systems for documentation approval workflows.
• Excellent communication skills for client coordination, deviation reporting, and cross-functional collaboration.
• Ability to analyze fabrication drawings with a focus on process and safety compliance.

Certifications (Preferred):

• Regulatory training/certifications related to USFDA, MHRA, ANVISA, TGA, WHO, ISO-QMS/EMS/OHSMS, MOHAP-UAE.