Job
Description
The individual will be responsible for setting up and functioning of injectables and Oral Solid Dosage (OSD) formulation plant functioning. He will coordinate and liaise with various internal and external consultants right from design stage through construction, commissioning, and maintenance of the formulation plant. Candidate must possess in-depth understanding of formulation plant designs as per FDA and EU-GMP guidance / expectations. Candidate must have built Lyophilizers and Isolators based high potent compound-based formulation facilities preferably in both injectable and OSD or at least injectable for the regulated markets. Experience 12 to15+ years of experience with at least 5-6 years of experience in formulation manufacturing projects site execution . Location Indore Qualifications Diploma / B.E 12 to 15+ years of experience with at least 5-6 years of experience in formulation manufacturing projects design and site execution . ResponsibilitiesExperience in green field project management including design, construction, comprehensive validations and maintenance within cGMP norms with successful formulation project outcome. Preferably should have handled Steroidal-hormonal Or Oncology or other high potent compounds Formulation projects. Should have handled designing, construction, and commissioning of Lyophilizers and isolators-based injectable and or OSD plants for regulated markets. Experience in using Project Management Software and tools. Project scope definition, organization and planning. Coordination with External consultant / Engineers, agencies and in-house various Function heads. Project labor requirements and budget Protocol and SOP development, scheduling, and implementation He should have knowledge & experience of Injectable equipment’s like. Isolator, Washing, Filling sealing and packing equipment’s.The Engineer would be required to take care of Design of the facility & Day to day coordination of activities at site.Will be directly involved in Process equipment’s selection, documentation, and Utilities design and installation activities at site.Engineer would be required to take care of Design of the plant, HVAC, Water system and all major components of the manufacturing plant.Engineer is required to be well versed with Area classifications, Zoning, Differential pressures requirements, and containment’s of the pharmaceutical industry.Engineer would be required to directly interact with internal stakeholders (Production, QA, Safety, TTC etc) & external agencies (Consultants, PMC’s, Vendors etc). Engineer would be required to analyse & evaluate all the Drawings before release of same to site for execution.Will have to make & monitor daily progress records at site.Will also involve travelling to certain extent for various coordination meetings at Consultants office & Head office.Will have to travel to works of various suppliers for FAT’s & stage wise inspections as well.Will have to do the technical evaluation of the technical specifications of all components, coordination with vendors for supplies & documentations (DQ/IQ/OQ etc).Will have to coordinate with consultants & vendors for timely availability of drawings and details at site.Will have to maintain the complete records of drawings & documents released to site.He is required to have working knowledge of AutoCAD & Microsoft Project.He should be well versed with various standards of Mechanical Engineering, ASME & ASTMA guidelines.He should have knowledge & experience of Pharmaceutical Industry. Key Deliverables Directing and managing the suppliers, liaising with Quality team, gap identification and risk mitigation and abiding to scheduled deadlines. Complete familiarity and knowledge of cGMP, CAPA and SHE. Demonstrated success in managing plant processes Key Competencies Experience in managing injectables and oral solids plant. Directing and managing the research activities to scheduled deadlines Complete familiarity and knowledge of cGMP and GLP. Extensive understanding of the formulations manufacturing process. Good knowledge of regulated environment and cGMP. Personal attributes Individual with a proactive management style characterized by effective leadership, commitment, enthusiasm, communication and teamwork Ability to collaborate successfully with both internal and external stakeholders to achieve company objectives Self-motivated, team player and efficient problem solver
