Job Description

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 Type: Full-time

Pay: ?40,377.52 - ?70,620.18 per month

Work Location: In person