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Summary:
The person will be responsible for the Reviewing and overseeing the analysis and review of analytical work (method development, pre-validation, validation, technology transfer and analysis of stability sample) performed at Complex Product Development team, GPRD, following GxP practices. The Person is also responsible to provide analytical support to Baxter Global, and Baxter’s Contract manufacturing sites as required.
Essential Duties and Responsibilities:
· To plan and perform sample analysis (analytical method development, validation, technology transfer, etc) activity following GxP & GDP practices for regulatory submissions for complex injectables like peptides, iron formulations, etc. Assist in regulatory query responses for Complex Products.
· To monitor the peers and help them in advancing the studies wherever required in timely manner.
· To plan the testing of Complex Injectable samples, including, API, development, validation, stability, bulk hold, RLD, PDR and any other samples as required, according to appropriate method of analysis.
· To be competent in analytical problem-solving, focus on innovation, process improvement and operational excellence. Knowledge of published literature and databases is essential.
· To keep track of all activities related to product analysis, ensure completion in the stipulated time, and inform the Sub-department manager if any deviation or issues observed.
· Preparation and review of analytical reports, SOPs and MOAs by referring to GQP & current pharmacopoeia as per requirement.
· To carry out all testing and data recording according to the approved SOPs following GDP & ALCOA++ principles and current pharmacopoeia. Ensure data recording in ELN with timely sign off and closure.
· To use appropriate reference and working standards for analysis and maintain their records. To verify the shelf life of the chemical or reagent before performing analysis of the material or product.
· To review the calibration records of the instruments as per approved standard operating procedure performed by Subordinates.
· To perform or review the calibration records of instruments as per approved SOPs. To check pre-requisites, assist in installation and qualification of laboratory instruments in timely manner as per organization requirement.
· To keep track of each activity related to product analysis and development activities
· To manage preventive & breakdown maintenance, perform risk assessment and suggest immediate corrective actions as and when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.
· To Report and investigate any failure / abnormal observation / OOT / OOS / deviation / Non-Compliance to sub-department manager and seeking for the solutions.
· To verify the shelf life of the chemical or reagent before performing analysis of the material or product.
· To verify all resources required for the study, keep track of routine requirements, ensure timely procurement of the same, and verify the materials received for analysis from suppliers.
· To review stability program for finished product, monthly data logger reports and qualification documents for stability chambers.
· To ensure timely review of DMF of API vendors, manage API and Excipient Vendor Approval process of New Product and existing products.
· To review the status of daily work of the team and report to the Manager.
· To check Preventive Maintenance, Breakdown maintenance and perform risk assessment and suggest immediate corrective actions as an when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.
Administrative:
· To plan work schedule as per requirement by respective department.
· To liaise with customers, staff, and suppliers.
· To respond to the query in the stipulated timeline.
· To ensure documentation is in line with analysis.
· To monitor compilation required data for Management Information System and provide to Sub-department Manager.
· To perform the documentation and QMS related activity using applications software like TCU, Trackwise, etc.
Communication to the management / superiors:
· To communicate any failure, deviation or abnormal notification or non-compliance in results to Sub- department Manager for their attention and work towards a solution
· To communicate project related issues to Sub-department Manager and follow the action plan.
· To keep status of daily work and report to Sub-department Manager on daily basis.
Key technical skills:
- Good experience in the execution of analytical method development, validation and technology transfer and routine analysis for peptides and iron colloidal drug products for regulatory submission.
- Competency with method relevant to iron DS/DP analysis, including particle size distribution by gel filtration chromatography, light scattering/diffraction/obscuration methods, assay of various iron forms, e.g. ferrous, ferric, labile iron, chelation assays, reduction potential and kinetics, etc, is strongly desired.
- Basic Knowledge and execution of Chemical Analysis using techniques relevant to complex injectables
- Knowledge of pharmacopoeia, ICH Guidelines.
- Execution of Operational and Calibration of Instrument on periodic basis
- Trouble shooting of various problems obtain during the during analysis.
- Knowledge of Transfer of Technology.
- Knowledge of Good Laboratory Practice and Good Documentation Practices
Key behavioral attributes:
· Communication skills
· Presentation skills
· Analytical skills
· Lateral coordination
· Positive Attitude
· Policy compliance
· Documentation Skills
· Problem Solving
Job Description (Grade 16)
Summary:
The person will be responsible for the Reviewing and overseeing the analysis and review of analytical work (method development, pre-validation, validation, technology transfer and analysis of stability sample) performed at Complex Product Development team, GPRD, following GxP practices. The Person is also responsible to provide analytical support to Baxter Global, and Baxter’s Contract manufacturing sites as required.
Essential Duties and Responsibilities:
· To plan and perform sample analysis (analytical method development, validation, technology transfer, etc) activity following GxP & GDP practices for regulatory submissions for complex injectables like peptides, iron formulations, etc. Assist in regulatory query responses for Complex Products.
· To monitor the peers and help them in advancing the studies wherever required in timely manner.
· To plan the testing of Complex Injectable samples, including, API, development, validation, stability, bulk hold, RLD, PDR and any other samples as required, according to appropriate method of analysis.
· To be competent in analytical problem-solving, focus on innovation, process improvement and operational excellence. Knowledge of published literature and databases is essential.
· To keep track of all activities related to product analysis, ensure completion in the stipulated time, and inform the Sub-department manager if any deviation or issues observed.
· Preparation and review of analytical reports, SOPs and MOAs by referring to GQP & current pharmacopoeia as per requirement.
· To carry out all testing and data recording according to the approved SOPs following GDP & ALCOA++ principles and current pharmacopoeia. Ensure data recording in ELN with timely sign off and closure.
· To use appropriate reference and working standards for analysis and maintain their records. To verify the shelf life of the chemical or reagent before performing analysis of the material or product.
· To review the calibration records of the instruments as per approved standard operating procedure performed by Subordinates.
· To perform or review the calibration records of instruments as per approved SOPs. To check pre-requisites, assist in installation and qualification of laboratory instruments in timely manner as per organization requirement.
· To keep track of each activity related to product analysis and development activities
· To manage preventive & breakdown maintenance, perform risk assessment and suggest immediate corrective actions as and when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.
· To Report and investigate any failure / abnormal observation / OOT / OOS / deviation / Non-Compliance to sub-department manager and seeking for the solutions.
· To verify the shelf life of the chemical or reagent before performing analysis of the material or product.
· To verify all resources required for the study, keep track of routine requirements, ensure timely procurement of the same, and verify the materials received for analysis from suppliers.
· To review stability program for finished product, monthly data logger reports and qualification documents for stability chambers.
· To ensure timely review of DMF of API vendors, manage API and Excipient Vendor Approval process of New Product and existing products.
· To review the status of daily work of the team and report to the Manager.
· To check Preventive Maintenance, Breakdown maintenance and perform risk assessment and suggest immediate corrective actions as an when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.
Administrative:
· To plan work schedule as per requirement by respective department.
· To liaise with customers, staff, and suppliers.
· To respond to the query in the stipulated timeline.
· To ensure documentation is in line with analysis.
· To monitor compilation required data for Management Information System and provide to Sub-department Manager.
· To perform the documentation and QMS related activity using applications software like TCU, Trackwise, etc.
Communication to the management / superiors:
· To communicate any failure, deviation or abnormal notification or non-compliance in results to Sub- department Manager for their attention and work towards a solution
· To communicate project related issues to Sub-department Manager and follow the action plan.
· To keep status of daily work and report to Sub-department Manager on daily basis.
Key technical skills:
- Good experience in the execution of analytical method development, validation and technology transfer and routine analysis for peptides and iron colloidal drug products for regulatory submission.
- Competency with method relevant to iron DS/DP analysis, including particle size distribution by gel filtration chromatography, light scattering/diffraction/obscuration methods, assay of various iron forms, e.g. ferrous, ferric, labile iron, chelation assays, reduction potential and kinetics, etc, is strongly desired.
- Basic Knowledge and execution of Chemical Analysis using techniques relevant to complex injectables
- Knowledge of pharmacopoeia, ICH Guidelines.
- Execution of Operational and Calibration of Instrument on periodic basis
- Trouble shooting of various problems obtain during the during analysis.
- Knowledge of Transfer of Technology.
- Knowledge of Good Laboratory Practice and Good Documentation Practices
Key behavioral attributes:
· Communication skills
· Presentation skills
· Analytical skills
· Lateral coordination
· Positive Attitude
· Policy compliance
· Documentation Skills
· Problem Solving
Education and/or Experience:
· Educational Qualification: Master’s in pharmacy/science, or PhD
· Experience: 8 to 12 years (MPharm) or 5+ (PhD)
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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