0 years
0 Lacs
Mumbai, Maharashtra, India
Posted:2 weeks ago|
Platform:
On-site
Full Time
Dear Candidate, Job Opening for the position of Engineer-Process and Equipment's-Thane Exp-4 yrs+ Job Description Review the process flow as per customers requirement. Develop process flow for all pharmaceutical formulations by self. Create capacity and cycle time analysis with help of Project Manager and define equipment sizing. Create Technical Specification and Data Sheets for production, packaging and processequipments. Float inquiries to vendors to get offers for production, packaging and process equipments. Follow-up to get the offers and solve technical queries of vendors in coordination with ProjectManager / Client to get correct technical offers. Make comparative statement of the offer Technical and Commercial. Troubleshoot the same withthe vendor to get at par basic data and requirement. Organize meetings with vendors, Get involved in vendor meetings to finalize the equipments on technical front as per TSrequirement. On decision from client / Project / Purchase team for procurement of equipments give the relevanttechnical details for preparation of PO. After PO release activity start coordinating with vendor for release of FAT, DQ, IQ, OQ and PQprotocols and working files. Ensure that all steps of documentation are followed and correct approvals and signatures are availed for future use of document. During each testing and qualification activity give the necessary protocols to the testing engineer and get the completed report from same respectively. Check and Verify all documents for missing certificates or documents as per requirements and get it coordinated and completed with the vendors. Prepare the final documentation for submission for further checking from validation department. Coordinate with site engineers on probable issues faced during testing and commissioning of the equipment and get it resolved with the respective vendors. Skills And Knowledge Knowledge of pharmaceutical formulations processes and equipments used in the system. Detailed knowledge of the pharmaceutical industry in general, dosage forms in the formulationindustry, various equipments and systems that go into the operation and construction of a facility. Fluent in both written and spoken English and Hindi. Self-starter and motivated to achieve goals and targets. Should be able to draft templates and documents as per standard requirements. Preferred - Should have adequate knowledge of the latest food and drug administration (FDA) requirementson documentation for equipments. Good knowledge of qualification and validation documentation for pharma process, packagingand production equipment. Should be able to draft Technical Specifications independently with minimum guidance. Attending practical validation or working on the production floor would be an added advantage. Mail CV at hr@lotustechnicals.com Thanks and Regards, Lotus technicals Pvt Ltd Thane West This job is provided by Shine.com Show more Show less
Lotus Group
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