Job Description

Department DetailsRole Summary1. ENSURE PROCESS EQUIPMENT ARE QUALIFIED THROUGH COMPREHENSIVE STRATEGIES AND AT THE STATE OF QUALIFICATION AT ALL TIMES. THIS INCLUDES AND NOT LIMITED TO CLEANING VALIDATION, EQUIPTMENT VALIDATION (IQ, PQ), PROCESS VALIDATION (PQ, PV), RE-QUALIFICATIONS, SAT, FAT\'S.
2. LEAD TECHNOLOGY TRANSFER PROCESSES, ASSESS FACILITY FIT, ASSESS EQUIPMENT CAPABILITY, PACKAGING AND MANUFACTURING EQUIPMENT AND PROCESS TROUBLESHOOTING, PROPOSE OPERATIONAL STRATEGY TOWARDS ENSURING OPTIMAL UTILIZATION OF THE EQUIPMENT AND FACILITY AND ENSURE HIGH QUALITY PRODUCT DELIVERIES
3. HAVE COMPLIANCE BACKGROUND IN THE PHARMACEUTICAL OR BIOTECHNOLOGY INDUSTRY
4. On time validation activities. First time right technology transfers systems. Design procedures to leverage equipment capabilities, proactive capacity and capex planning systems creation and adherence
5. In depth understanding of biotechnology and aseptic pharmaceutical manufacturing processes, facility design aspects and cGMP and GEP knowledge beside soft skills like people and systemic thinking
6. In depth validation and qualification knowledge
7. In depth of technology transfer knowledge
8. In depth process equipment knowledgeKey Responsibilities1. ENSURE PROCESS EQUIPMENT ARE QUALIFIED THROUGH COMPREHENSIVE STRATEGIES AND AT THE STATE OF QUALIFICATION AT ALL TIMES. THIS INCLUDES AND NOT LIMITED TO CLEANING VALIDATION, EQUIPTMENT VALIDATION (IQ, PQ), PROCESS VALIDATION (PQ, PV), RE-QUALIFICATIONS, SAT, FAT\'S.
2. LEAD TECHNOLOGY TRANSFER PROCESSES, ASSESS FACILITY FIT, ASSESS EQUIPMENT CAPABILITY, PACKAGING AND MANUFACTURING EQUIPMENT AND PROCESS TROUBLESHOOTING, PROPOSE OPERATIONAL STRATEGY TOWARDS ENSURING OPTIMAL UTILIZATION OF THE EQUIPMENT AND FACILITY AND ENSURE HIGH QUALITY PRODUCT DELIVERIES
3. HAVE COMPLIANCE BACKGROUND IN THE PHARMACEUTICAL OR BIOTECHNOLOGY INDUSTRY
4. On time validation activities. First time right technology transfers systems. Design procedures to leverage equipment capabilities, proactive capacity and capex planning systems creation and adherence
5. In depth understanding of biotechnology and aseptic pharmaceutical manufacturing processes, facility design aspects and cGMP and GEP knowledge beside soft skills like people and systemic thinking
6. In depth validation and qualification knowledge
7. In depth of technology transfer knowledge
8. In depth process equipment knowledgeEducational QualificationsRequired Education Qualification: B.Pharma
Required Experience: 1 - 5 years

Biocon