Quality Assurance Executive

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