Quality Assurance Analyst
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 were #27 in 2010)
Job Overview:
Under the oversight of the Director, QA and Technical Services, the Quality Assurance Analyst will be responsible for reviewing all finished product batches for compliance with applicable regulatory and cGMP requirements prior to release for commercial distribution.This position will also provide support to in-house and external product development activities. This includes performing and/ or assisting with internal and external cGMP audits of FP and API manufacturing sites, compliance review of CMC sections of aNDA/ Regulatory filings and liaison with GMP contractors as dictated by the development project(s).
Maintenance and/ or improvement of the quality systems necessary to support GMP related activities will also be required.
Responsibilities:
- Review and disposition finished drug products for commercial distribution.
- Review investigations related to finished drug products to assure root causes are identified and appropriate CAPAs identified to prevent
- Maintain Document Control and Quality systems.
- Maintain standard operating procedures (SOPs)
- Maintain finished drug product specifications.
- As assigned by the QA Director, review ANDAs for accuracy and adequacy (focusing on the Sterility Assurance and stability sections).
- Maintain Quality Agreements with internal APL divisions and external partners are kept up to date
- Support Aurobindo USA Pharmacovigilance on an as needed basis on finished drug product complaints and customer
- Review, and/or approve validation documents, deviations, and change controls related to finished drug
- Coordinate and/or support in obtaining any establishment and/or state licenses
- Perform cGMP audits of internal and external partners, vendors, as required.
- 1 Provide periodic updates to QA Director on Quality related issues.
Qualifications - Skills & Requirements:
- BS/BA Degree in Microbiology, Chemistry or Pharmacy preferred
- Minimum of 3 years experience in the Pharmaceutica/Biotech industry with knowledge of cGMP regulations as they pertain to API and sterile finished drug products
- Minimum of 3 years in Quality Assurance/Compliance. Experience with batch disposition, investigation and/or cGMP Compliance Auditing is preferred.
- Experience working in a Microbiology or Analytical Chemistry Laboratory or in a Sterile/injectable drug manufacturing facility
- Ability to work independently
Education & Experience:
- BS/BA Degree in Microbiology, Chemistry or Pharmacy preferred
- Min 3 years experience in the Pharmaceutica]/Biotech industry with knowledge of cGMP regulations as they pertain to API and sterile finished drug products
- Experience with batch disposition, investigation and/or cGMP Compliance Auditing is pref erred.3 years' in Quality
- Experience working in a Microbiology or Analytical Chemistry Laboratory or in a Sterile/injectable drug manufacturing facility
- Ability to work independently
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.
- 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.
Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical 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.