Website Aurobindo Pharma USA, Inc.
Aurobindo Pharma USA, Inc.
Company : 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)
Job Overview:
Under the oversight of the Senior Manager, Quality and Complianc this position will be responsible for documentation and training for Aurobindo Pharma USA and assist compliance with applicable regulatory and cGMP requirements with respect to Change Controls, Deviations, CAPA, etc.
This position will also provide support subsiaries of Aurobindo Pharma USA as applicable.
Responsibilities:
• Work with regional management to maintain and improve a Quality System
for US Region
• Requires conformance to all SOP’s Procedures, Policies and regulations (21
CFR 210 211), including OSHA requirements and Safety Procedures.
• Maintain and improve the QA Process of Document Review and Approval.
• Person will be responsible for the activities related to QA Documentation
department related to Training and Documentation work functions.
• Some of activities are working on Caliber programs i.e.: Nichelon, DMS, and
QAMS.
• Ensure Compliance of QA Controls with the Company’s best practice and
standards.
• Participate in Regulatory inspections and Related follow up activities.
• Will aid management with the preparation to generate required documentation
for regulatory inspections and customer audits.
• Review and ensure the content is accurate and meets requirements for the
Review Period.
• Preparing, maintaining, revising SOP’s
• Making approved cGxP documents effective
• Maintain the standards for accuracy.
• Work with Manager and HR to ensure training needs to make
recommendations.
• Conduct and present NEO training as scheduled, initiate/assist with printing
forms, train and grade on respective quizzes.
• Ensure all training documents received are neat, legible, accurate and
complete.
• Tracking of all Training to include job Specific Training, developmental
training, GMP, Safety, Compliance etc.
• Participate in Global implementation Procedures/Policies Trainings.
• Assist in Scheduling and Coordinating of on-Site Training Sessions.
• Collaborate with Department Training Coordinator to ensure training
materials are accurate and up to date.
• Evaluate the effectiveness of training programs and recommend
improvements.
• Ensure all communication is delivered to respective team members.
• Collaborate with Site Head(s) to ensure that Annual GMP, Quality Culture
Policies and Safety trainings are conducted yearly.
• Upon request, all other duties which may be assigned.
Qualifications – Skills & Requirements:
BS/BA Degree: Preferred in Science or Regulatory related field
2-4 years’ experience in Pharmaceutical Quality Assurance/Compliance or additional education with knowledge of cGMP regulations.
Position requires the ability to engage in an effective and collabrative manner across subsidiaries and teams
This position requires the applicant to communicate and write proficiently in the English language.
Ability to work independently
Position is considered Sedentary in nature, requiring ability to sit at a computer terminal for extended periods occasionally requiring the ability to move and lift approximately 10-25 lbs.
Education & Experience:
BS/BA Degree: Preferred in Science or Regulatory related field
2-4 years’ experience in Pharmaceutical Quality Assurance/Compliance or relevant education with knowledge of cGMP regulations.
Internal and External (Regulatory) Audit experience preferred
Compensation: $24.00 to $26.00 an hour, annual bonus
• Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
• Dental Benefits with three dental plan options through CIGNA
• Vision Plan with two plan options through VSP
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability • Long-Term Disability (LTD), State (short term) disability – where applicable
• FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 401(k) Plan – Through Fidelity/ Employer Match / fully vested after 3 years
• Employee Assistance Program (EAP) – 100% Confidential and 100% company paid
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off – Paid vacation, PTO, Holidays
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 Physical Requirements:
No Additional Requirements
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.