Job Description

Process Manager should have a strong understanding of Pharmaceutical Projects for all dosage forms of OSD, Sterile, Topical and Liquid Manufacturing products (Cytotoxic Product will be an advantage). Should have a firm hand on experience into the Feasibility, Process Study, Process Risk Analysis, Concept Designing for Pharma Projects. Well versed with relevant guidelines like EU GMP, US FDA, PIC/S, Schedule M, ISPE, cGMP, GSP, GLP, ISO, GxP, 21 CFR, Indian Pharmacopeia (IP), British Pharma-copeia (BP), US Pharmacopeia (USP), etc. Should have handled at least process of pharmaceutical manufacturing project and Laboratory with Microbiology. Self-Starter, motivator, team player. Will be independently dealing with the Client, Vendors and Suppliers, internal resources apart from Project Management, Project Progress Reports & necessary Reports to the project team.

Essential Duties & Responsibilities

Provide effective leadership, coaching and conflict resolution to the project team in order to meet project goals and objectives Independently capable of doing process flow diagram, batch size calculation, process balance, equipment sizing, working area calculation, risk analysis, FMEA, VMP, CQV, QMS, etc. Independently capable of preparing URS for process equipment. Review of DQ documents, GAD, etc. of the vendor as per required process and guidelines. Coordinate multi-discipline for providing the utility requirements for the process equipment. Independently capable of doing time cycle charts for the clean utilities. Contribute to Standards and Guidelines Development (Providing Project Concept notes as per latest selected guide lines), Upgrade and comply latest (world class) standards and modifications in all projects. Manage relations with international clients and have willingness to travel. Independently capable of doing FAT, SAT, DQ, IQ and OQ. End responsibility within our projects for all Process Engineering from the quotation phase, over design till qualification and handover to the client in projects for Pharmaceutical. Having knowledge of process automation and optimization. Preparation and review the layouts in the process perspective and understanding the client's process requirement. Act as SME for process & equipment, driving requirements in the design/selection of process equipment. Follow and anticipate process technology and design industry trends and knowledge transfer to the team. Manage relations with international clients and have willingness to travel. Preparation of PFD (Process Flow Diagram) and P&IDs (Piping & Instrument diagram) for Process.

Required Skills and Experience

Education

BE Mechanical or any Engineer/B. Pharm / M. Pharm / PhD from Government College / Regional College (REC) / any other College of repute.

Experience

Min 10-15 years of total professional experience in Process design and execute pharmaceutical projects either with a pharmaceutical company's technical organization or with an engineering/consulting company.

Functional Competencies

Process Design Planning & Execution Knowledge of cGMP, ISPE, GSP, GLP, ISO and other engineering guidelines etc. Good Command over AutoCAD + MS Project Ability to handle team effectively

Behavioral Competencies

Result Focus Innovative thinking Time Management Problem solving ability & High level of self-motivation Strong inter-personal relationship skills * Strong written & verbal communication