Documentation Engineer- pharmaceutical engineering

1 day ago

Mumbai, Maharashtra, India lifecraft engineering Full time

Building Excellence Through Pharmaceutical Innovation

At Lifecraft Engineering, we don't just build pharmaceutical systems we craft trust, precision, and progress. Driven by innovation and a commitment to global quality and regulatory excellence, we create turnkey solutions that empower the healthcare world to move forward with confidence. Our mission is simple yet powerful: to engineer the future of wellness and help industries touch more lives with reliability, integrity, and purpose.

Key Responsibilities

Project Documentation Management: Plan, direct, and coordinate the preparation, flow, and filing of all project documentation, including engineering drawings, specifications, technical manuals, and contract modifications.

Regulatory Compliance: Ensure all documentation adheres to stringent local and international pharmaceutical manufacturing regulations (such as USFDA, EMA, and WHO guidelines).

Validation & Qualification Documentation: Prepare, review, and execute qualification protocols (DQ, FAT, SAT, IQ, OQ, PQ) for equipment, facilities, utilities, and processes, and compile final reports.

SOP Development: Develop and implement Standard Operating Procedures (SOPs) for all stages of production, quality control, maintenance, and documentation processes.

Collaboration & Information Gathering: Work closely with cross-functional teams including design, engineering, production, QA/QC, and external vendors/clients to gather and verify technical information and ensure clarity and accuracy in all documents.

Document Control Systems: Manage and maintain robust document control systems (electronic and physical), ensuring proper version control, accessibility to authorized personnel, and secure archiving of records.

Audit Support: Provide support during internal and external regulatory audits and inspections, ensuring all documentation is readily available and complete.

Training: Assist in training personnel on new or updated documentation, procedures, and quality standards.

Deviation and Change Control Management: Lead or support the documentation aspects of change controls (CCFs), deviations, and Corrective and Preventive Actions (CAPAs), including root cause analysis and investigation reports.

Technical Knowledge:

Strong understanding of GxP (GMP, GLP, GDP) guidelines and quality management systems (QMS).

Familiarity with validation processes (IQ/OQ/PQ) and equipment qualification.

Proficiency in documentation software and tools (e.g., MS Office, Adobe FrameMaker, Confluence), and potentially AutoCAD or ERP systems.

Soft Skills:

Excellent written and verbal communication skills.

Strong attention to detail and analytical skills.

Ability to work independently, manage multiple projects, and meet tight deadlines.

Job Types: Full-time, Permanent

Pay: ₹20, ₹42,620.18 per month

Work Location: In person

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