Job
Description
To manage the Projects Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities including developing the Protocols and execution of reports for Pharmaceutical OSD / Injectable / API / Oncology / Biotechnology /Vaccine manufacturing facilities. Responsible for handling multiple projects Commissioning & Qualifications activities considering end to end Project management. Will also be responsible for organizing, budgeting, scheduling, executing & monitoring the performance of project as per required timelines. About the Role: To manage the Projects Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities including developing the Protocols and execution of reports for Pharmaceutical OSD / Injectable / API / Oncology / Biotechnology /Vaccine manufacturing facilities. Responsible for handling multiple projects Commissioning & Qualifications activities considering end to end Project management. Will also be responsible for organizing, budgeting, scheduling, executing & monitoring the performance of project as per required timelines. Key Responsibilities: Responsible for Preparation/execution/compiling of Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities Protocols/reports for the Pharmaceutical facilities which includes OSD / Injectable / API / Oncology / Biotechnology /Vaccine manufacturing facilities. Responsible for onsite support C&Q activities by following ISPE/ASTM methodologies utilizing GDP, GEP, C&Q Base line guides, GAMP 5 & cGMP Principles. Planning, developing, execution, reporting of C&Q Deliverables. Coordination with different package design engineers & Clients, Project managers to enable effective leveraging and timely Right First Time Documents preparations, execution and compliance of Commissioning & Qualification deliverables In depth knowledge of Regulatory Guidelines- USFDA, MHRA, WHO, ISO, 21 CFR part 11 & other regulatory guidelines Preparations of Commissioning & Qualifications Protocols/ Standard operating Procedures/ Work instructions as applicable Prepare/ Review of Validation master plan, Validation plans, Validation Documents, Commissioning & Validation execution of Clean Room & HVAC Systems (Such as DQ, IQ, OQ & PQ) in Pharmaceutical Industries as per the required standards Preparation and review of qualification protocols, Temperature mapping protocols, Layouts and SOPs as per established procedures. Preparations & execution of Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipments Preparation & execution of Facility, Utility & process equipment FAT/SAT Protocols/Reports Essential Requirements: Degree in Mechanical/Chemical Engineering with 10 - 12 years of experience in Pharmaceutical/ Chemical/ FMCG Industry. Deep understanding of Project Commissioning & Qualification activities like Facility/HVAC/Clean room / Black & Clean Utility services/Process equipment within pharmaceutical OSD / Injectable / API / Oncology / Biotechnology Good Knowledge of Project management like - Project planning, Cost Management, Time Management, Construction management, Quality Management, Contract Administration, Safety Management & required Statutory approvals management. Desirable Requirements: Degree in Mechanical/Chemical Engineering or equivalent. Fluent in English and proficient in local language.
