Process Specialist

Ensuring the compliance of Lindström Service concepts and operations with international management system standards and customer requirements. Focus of this role is Independently support Cleanroom Operations.Responsibilities:Process implementation related to Cleanroom Service (CRS)Executing / Implementing Documentation in accordance to EU cGMP and other required standard and Lindström Management System guidelinesMonitor the agreed process KPIs and support to improve the operational excellence.Closely work with Cleanroom team and understand and develop the process parameters.Support and train the Unit personnel in handling customer's queries and technical write-up.Support and train the Unit personnel in identifying the change in work instructionsSupport and train the Unit personnel in analyzing the process risk and performing risk assessment.If required visit to customer for any support for technical queriesAudit units to see Linstrom process is getting followed properlyResponsible for implementing conceptualized processes and layoutPerform supplier audit as per defined frequencyAudit all the working and washing methods are followed in the unitsQualifications and Skills:The person should carry at least 10 - 15 years of experience in pharma cleanroom environment.Good knowledge and technical know how about the cleanroom and pharma standards.Good knowledge in ISO, EU cGMP, US pharmacopeia, IEST, Chinese pharmacopeia, Indian Pharmacopeia, will be preferred.Must have expertise in Autoclave system.Good knowledge in Good Documentation Practices for ensuring traceability of the management system.Knowledge on Microbiology will be added advantage.Ability to streamline and evaluate processes and their compliance with the quality standards.Good communication skills. PRB