: Pharmaceutical Documentation Engineer

- Role: Pharmaceutical Documentation Specialist (Site/Office)

- Location: Navi Mumbai, Maharashtra

Company designs and delivers high-purity water systems critical for the pharmaceutical industry, adhering to the strictest global standards (ASME BPE, cGMP, ISPE) and regulatory requirements (USFDA, MHRA, WHO). Quality and compliance are paramount in our work.

What You'll Do:

- Develop and manage comprehensive pharmaceutical-grade documentation throughout the project lifecycle.

- Prepare key qualification documents: Design Qualification (DQ), Functional Design Specification (FDS), Hardware Design Specification (HDS), Criticality Analysis, and Risk Assessments.

- Compile, organize, and manage test certificates and supporting documents for Installation Qualification (IQ) and Operational Qualification (OQ) activities, both in soft and hard copies.

- Oversee and contribute to Computer System Validation (CSV) documentation for automated systems involving PLC, HMI/IPC, and SCADA.





- Ensure all documentation meets industry standards and regulatory requirements.

What You Bring:

- A Diploma or Degree in Engineering.

- 2-3 years of experience specifically in pharmaceutical documentation or a similar quality/validation role within a regulated industry.

- Solid understanding and practical experience with DQ, FDS, HDS, Risk Assessments, IQ/OQ processes, and CSV principles.

- Meticulous attention to detail and excellent organizational skills.

- Familiarity with pharmaceutical standards (cGMP, ISPE, ASME BPE) is highly advantageous.

- Proficiency in managing documentation for PLC/SCADA controlled systems.

What We Offer:

- A specialist role ensuring compliance for critical high-purity water systems.

- Opportunity to work with advanced technologies in a quality-focused environment.

- Be part of a leading engineering company serving demanding industries.

📌 Pharmaceutical Documentation Engineer (Navi Mumbai)
🏢 Talent Corner HR Services
📍 Navi Mumbai