Quality Assurance Executive

You will be part of a greenfield project located in GIDC Vapi, covering an area of 10,556 sq m dedicated to the manufacturing of Pharma Intermediates and APIs. The project is designed to include a main intermediate production building, a GMP facility, and infrastructure for Catalytic Hydrogenation, emphasizing sustainable practices and competitive innovation. Your responsibilities will involve the preparation and upkeep of Engineering/Project documentation, Qualification & Validation documents throughout the various stages of the greenfield project until commercial manufacturing. It is essential to ensure the implementation and adherence to industry/cGMP best practices. This includes creating Qualification documents such as URS, DQ, IQ, OQ & PQ for production and utility equipment, as well as overseeing Engineering documents encompassing certificates, calibration, test results, inspection requests, non-compliance reports, and other crucial QA/QC documents. You will be accountable for tasks like conducting factory acceptance tests at vendor sites, qualifying new equipment, and periodically re-qualifying equipment and facilities like PW plant HVAC. Additionally, you will be involved in the Preparation & Review of SOPs for the Engineering department, Training and Approval of Qualification SOPs, preparing Facility qualification documents, and developing Project-specific qualification plans for significant changes. Your role will also entail the creation of various documents such as Installation and operational qualification protocols and reports, Performance Qualification Protocols and reports, and conducting training sessions for new hires and Executives on Qualification Activities. To qualify for this role, you should hold a BE/ BTech degree in Chemical/Mechanical Engineering with a background of 5-10 years in Engineering/Project documentation. Strong written and verbal communication skills will be beneficial for effectively carrying out the responsibilities associated with this position.,