What are the responsibilities and job description for the Packaging Documentation Associate position at Aurobindo Pharma USA, Inc.?
Division Overview
Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010) AuroPackaging (APK) is a division of Aurobindo USA that plays a primary role in converting the Bulk from our manufacturing sites to Finished Goods (FG) as per AuroHealth (AH) requirements.
Responsibilities
Job Overview
Gathering Data for packaging deviation investigation, performance of Root Cause Analysis to determine the most likely cause of the deviation, assessment of event for product/process impact, perform trending analysis. Identification and Execution of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Change Control Initiation and Executions to changes deriving from investigation and/or standalone changes. Accurately capture immediate actions and containment of the event, address comments from both internal and external audits on the compiled final report. Complete the packaging investigations on time. Prepare new SOP”s , revision of existing SOP’s and training of packaging operators on SOP’s. Works proactively in addressing potential issues and applies real-time problem solving skills when working towards resolution. Provides regular and timely reports and interpretation of results to the Packaging Manager. Review of packaging batch record as required. Follow company policies, cGMP’s and Standard Operating Procedures. Perform any and all additional tasks relating to the operation of the packaging department as requested.
Qualifications - Skills & Requirements
The ability to effectively build and maintain relationships and motivate a highly diverse team in order to effectively negotiate and solve problems. Ability to investigate issues, analyze root causes and define resolutions. The ability to facilitate and generate the exchange of ideas to resolve problems, select and prioritize optimal solutions and implement decisions. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency. The ability to maintain an attention to detail while executing multiple tasks. The ability to exhibit flexible thinking. A continuous improvement and quality mindset. A willingness to develop yourself and others. Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, DEA regulations and/or MSDS.
Education & Experience
Bachelor of Science degree preferred 1-3 years of work experience in a pharmaceutical packaging environment with proven technical writing skills.
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to:
Sitting 1-4 HoursWalking 1-4 HoursSitting 5-8 Hours Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
We Are An Equal Opportunity Employer
Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training., The ability to effectively build and maintain relationships and motivate a highly diverse team in order to effectively negotiate and solve problems. Ability to investigate issues, analyze root causes and define resolutions. The ability to facilitate and generate the exchange of ideas to resolve problems, select and prioritize optimal solutions and implement decisions. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency. The ability to maintain an attention to detail while executing multiple tasks. The ability to exhibit flexible thinking. A continuous improvement and quality mindset. A willingness to develop yourself and others. Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, DEA regulations and/or MSDS., Gathering Data for packaging deviation investigation, performance of Root Cause Analysis to determine the most likely cause of the deviation, assessment of event for product/process impact, perform trending analysis. Identification and Execution of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Change Control Initiation and Executions to changes deriving from investigation and/or standalone changes. Accurately capture immediate actions and containment of the event, address comments from both internal and external audits on the compiled final report. Complete the packaging investigations on time. Prepare new SOP”s , revision of existing SOP’s and training of packaging operators on SOP’s. Works proactively in addressing potential issues and applies real-time problem solving skills when working towards resolution. Provides regular and timely reports and interpretation of results to the Packaging Manager. Review of packaging batch record as required. Follow company policies, cGMP’s and Standard Operating Procedures. Perform any and all additional tasks relating to the operation of the packaging department as requested.
Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010) AuroPackaging (APK) is a division of Aurobindo USA that plays a primary role in converting the Bulk from our manufacturing sites to Finished Goods (FG) as per AuroHealth (AH) requirements.
Responsibilities
Job Overview
Gathering Data for packaging deviation investigation, performance of Root Cause Analysis to determine the most likely cause of the deviation, assessment of event for product/process impact, perform trending analysis. Identification and Execution of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Change Control Initiation and Executions to changes deriving from investigation and/or standalone changes. Accurately capture immediate actions and containment of the event, address comments from both internal and external audits on the compiled final report. Complete the packaging investigations on time. Prepare new SOP”s , revision of existing SOP’s and training of packaging operators on SOP’s. Works proactively in addressing potential issues and applies real-time problem solving skills when working towards resolution. Provides regular and timely reports and interpretation of results to the Packaging Manager. Review of packaging batch record as required. Follow company policies, cGMP’s and Standard Operating Procedures. Perform any and all additional tasks relating to the operation of the packaging department as requested.
Qualifications - Skills & Requirements
The ability to effectively build and maintain relationships and motivate a highly diverse team in order to effectively negotiate and solve problems. Ability to investigate issues, analyze root causes and define resolutions. The ability to facilitate and generate the exchange of ideas to resolve problems, select and prioritize optimal solutions and implement decisions. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency. The ability to maintain an attention to detail while executing multiple tasks. The ability to exhibit flexible thinking. A continuous improvement and quality mindset. A willingness to develop yourself and others. Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, DEA regulations and/or MSDS.
Education & Experience
Bachelor of Science degree preferred 1-3 years of work experience in a pharmaceutical packaging environment with proven technical writing skills.
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to:
- Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
- Specific vision abilities required by this job include close vision requirements due to computer work
- Light to moderate lifting is required
- Moderate noise (i.e. business office with computers, phone, and printers, light traffic).
- Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional
Sitting 1-4 HoursWalking 1-4 HoursSitting 5-8 Hours Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
We Are An Equal Opportunity Employer
Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training., The ability to effectively build and maintain relationships and motivate a highly diverse team in order to effectively negotiate and solve problems. Ability to investigate issues, analyze root causes and define resolutions. The ability to facilitate and generate the exchange of ideas to resolve problems, select and prioritize optimal solutions and implement decisions. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency. The ability to maintain an attention to detail while executing multiple tasks. The ability to exhibit flexible thinking. A continuous improvement and quality mindset. A willingness to develop yourself and others. Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, DEA regulations and/or MSDS., Gathering Data for packaging deviation investigation, performance of Root Cause Analysis to determine the most likely cause of the deviation, assessment of event for product/process impact, perform trending analysis. Identification and Execution of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Change Control Initiation and Executions to changes deriving from investigation and/or standalone changes. Accurately capture immediate actions and containment of the event, address comments from both internal and external audits on the compiled final report. Complete the packaging investigations on time. Prepare new SOP”s , revision of existing SOP’s and training of packaging operators on SOP’s. Works proactively in addressing potential issues and applies real-time problem solving skills when working towards resolution. Provides regular and timely reports and interpretation of results to the Packaging Manager. Review of packaging batch record as required. Follow company policies, cGMP’s and Standard Operating Procedures. Perform any and all additional tasks relating to the operation of the packaging department as requested.
