Job Description

We are recruiting for a greenfield project in GIDC Vapi having area 10,556 sq m for manufacturing Pharma Intermediates and APIs. Planned facilities include main intermediate production building, GMP facility and set-up for Catalytic Hydrogenation, with a strong focus on green chemistry and competitive innovation. Roles and Responsibilities: The candidate will be responsible for preparing and maintaining Engineering/Project documentation, Qualification & Validation documents for greenfield project stage till commercial manufacturing, while ensuring implementation and compliance in line with industry / cGMP best practices. Preparation of Qualification document like URS, DQ, IQ, OQ & PQ for production and utility equipments. Responsible for Engineering documents of the complete project including certificates, calibration, test results, inspection requests, non-compliance reports and site instruction/observations, permanent materials delivered and other important QA/QC documents. Factory acceptance test at vendor site. Qualification of new equipment and periodic re-qualifications of equipment i.e. PW plant HVAC etc, facility, utilities. Preparation & Review of SOPs for Engineering department. Training and Approval of Qualification SOP. Preparation of Facility qualification document. Preparation and Approval of Project specific qualification plan for all major changes. Document Preparation, Installation and operational qualification protocol and reports. Performance Qualification Protocol and reports. Responsible for conducting training to new joinees and Executives regarding Qualification Activities. Qualifications: BE / BTech in Chemical / Mechanical Engineering 2-4 years in Engineering/Project (Documentation ) Good written and verbal communication skills

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