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: ₹20,377.52 - ₹42,620.18 per month
Work Location: In person
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