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.
