Execution of planned preventive maintenance, Calibrations with team of operators, supervisors working in three shifts. Qualification of machine, periodic maintenance co-ordination. Continuous improvement in productivity and maximum asset utilization.
cGMP compliance in the utilities supply, maintenance and process machine area on 24x7 basis.
Co-ordination with IPQA, QA and PPIC for smooth functioning of maintenance, Calibrations and qualification.
Imparting training, develop down the line skilled workforce and improve people and equipment efficiency.
Develop, Improve and implement SOPs, Protocols for validations, and other record formats relevant to repair and maintenance functions.
Co-ordinate with R&D and PDL to understand requirement of new products and changes in existing products.
Use statistical tools to improve productivity and efficiency of plant. Real time monitoring of critical costs like power and fuel and arrest any wastages.
Understand global regulatory expectations in engineering area to manufacture oral and sterile dosage forms and present them to various auditors, visitors.
Lead team in GMP documentation like deviations, Change controls, Incident and get involved in investigations.
Ensure compliance to plants EHS policy and related documentation.
Education : Minimum Graduate Engineer. Additional qualification in Industrial engineering, Computer applications, plant management is desired but not mandatory.
Experience : 10+ Years in pharmaceutical formulation manufacturing site. A significant part of experience shall be at site, catering to US/EU markets. Should have faced regulatory inspections for Oral as well as Sterile products.
Knowledge and Skills (Functional / Technical) : Pharmaceutical processes and related equipment design. Good Engineering Practices. GMP guideline of US/EU and India, in reference to engineering functions. Have skill set to manage utilities with productive output, minimize breakdown, statistical evaluation of plant performance and continuous improvement of productivity. Optimum utilization of budgetary resources.
Leadership / Managerial Attributes : Modest, Self-Confident, Initiator, Creative, Communicative, Responsible , trust worthy, Decisive, Technical Competence, People Skills
Other requirements (licenses, certifications, specialized training) : GMP documentation skill, EHS knowledge, factory laws knowledge. Understand and follow ethical work culture of company.
Computer : Proficient on MS Office, SAP, and general computer applications.
Engineering knowledge : Basic knowledge of mechanical,and Instrumentation engineering to effectively manage equipment maintenance.