For Infosys Post : Regulatory and Clinical Business Analyst
Job Description
• As part of the Infosys consulting team, your primary role would be to actively aid the consulting team in different phases of the project including problem definition, effort estimation, diagnosis, solution generation and design and deployment
• You will explore the alternatives to the recommended solutions based on research that includes literature surveys, information available in public domains, vendor evaluation information, etc. and build POCs
• You will create requirement specifications from the business needs, define the to-be-processes and detailed functional designs based on requirements.
• You will support configuring solution requirements on the products; understand if any issues, diagnose the root-cause of such issues, seek clarifications, and then identify and shortlist solution alternatives
• You will also contribute to unit-level and organizational initiatives with an objective of providing high quality value adding solutions to customers.
Candidate Profile
• Bachelor of Engineering,Bachelor Of Technology,Bachelor Of Comp. Applications,Bachelor of Pharmacy,Master of Pharmacy,Master Of Technology,Master Of Comp. Applications
• Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability
• Good knowledge on software configuration management systems
• Awareness of latest technologies and Industry trends
• Logical thinking and problem solving skills along with an ability to collaborate
• Understanding of the financial processes for various types of projects and the various pricing models available
• Ability to assess the current processes, identify improvement areas and suggest the technology solutions
• One or two industry domain knowledge
• Client Interfacing skills
• Project and Team management
Additional Information
Experience : 5-9 Years
Qualification : B.E, B.Tech, B.Pharm, M.Pharm
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID / Reference Code : INFSYS-EXTERNAL-193197
End Date : 25th October, 2024
For Sun Pharma –
Post : Sr. Officer / Executive
Department : Quality Assurance
Total years of experience : 3 – 7 Years
Education Qualification : B.Pharma /M.Pharma
Job role : In Process Quality Assurance
Job Description
• Ensure Compliance to cGMP for all operational activities.
• Conduct line clearances and in process checks at different stages of manufacturing and packaging
• Environment monitoring in manufacturing areas
• Sampling of water and cleaning validation
• Sampling of beta lactum monitoring/compressed air /nitrogen sampling
• To collect and submit the samples at different stages like intermediate samples, finished product samples, control samples, stability samples (if applicable) and shipment samples/references samples (if applicable)
• Monitor the API / formulated products against stipulated conditions mentioned in the batch production record.
• Conduct certification of batch production records for compliance and stage wise completion.
• Performing sampling and physical inspection of finished products.
• Conduct calibration of IPQA laboratory instruments.
• Give required support during validation studies.
• Line clearance for dispensing of raw material in Block A warehouse
• Controsample management of finished goods and API.
For Pfizer –
Post : Senior Safety Surveillance Associate
Job Description
• Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
• Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately.
• Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
• Review case criteria to determine the appropriate workflow for case processing.
• Write and edit the case narrative.
• Generate reports, ensuring adherence to regulatory compliance timelines.
• Determine appropriate case follow-up, requesting follow-up letters when appropriate.
• Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
• Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.
• Consistently apply regulatory requirements and Pfizer policies.
Candidate Profile
• Should be Health Care Professional (i.e, Pharmacy, Dentistry, Nursing.. etc).
• Pharmacovigilance or relevant experience: 0-6 years.
• Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
• Demonstrated computer literacy, particularly in the use and management of relational databases.