QUALITY ASSURANCE SPECIALIST

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 :

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a vital role in ensuring that our company maintains the highest standards of quality control and compliance.

Your primary responsibilities will include assisting with change controls, bill of materials, Oracle data management, customer audits, customer complaints, recalls, and quality test protocols.

If you are a dedicated and driven individual with a passion for quality control and compliance, we invite you to apply for the position of Quality Assurance Specialist.

Join our team and contribute to our mission of delivering high-quality products to our customers while maintaining regulatory compliance.

Responsibilities :

QMS (Quality Management System) : Assist in managing and documenting change control processes to ensure all changes are properly evaluated, approved, and implemented in accordance with company policies and regulations.

Handling of change controls, deviations, and CAPA in QAMS systems.

Bill of Materials : Maintain accurate and up-to-date bill of materials (BOM) to support manufacturing operations, ensuring that all components and materials are correctly listed and documented.

Oracle Data Management : Utilize Oracle or other data management systems to accurately record, track, and analyze quality-related data, ensuring data integrity and compliance with regulatory requirements.

Customer Audits : Support customer audits by preparing necessary documentation, participating in on-site audits, and addressing any quality-related inquiries or concerns raised by customers.

Customer Complaints : Assist in the management of customer complaints by investigating and documenting complaints, coordinating with relevant departments to address root causes, and implementing corrective and preventive actions.

Recalls : Collaborate with cross-functional teams to execute production authorities and timely and effective communication with customers and regulatory authorities, and coordinating the retrieval and disposition of affected products.

Quality Test Protocols : Assist in the development, implementation, and maintenance of quality test protocols, ensuring they are in compliance with regulatory requirements and industry standards.

Internal Audit : Conduct Internal Audit and ensure compliance with the observation in a timely manner. Coordinating with other departments to ensure compliance to procedure.

Coordinate, review, and compile batch related documents. Keep all GMP records in compliance with Good Documentation Practices.

Liase with manufacturing facilities and testing laboratory to facilitate the timely release of lots.

Review quality agreements with contract manufacturers.

Carry out failure investigations for any non-conformities.

Qualifications - Skills & Requirements :

Excellent organizational skills and attention to detail.

Effective communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.

Problem-solving and analytical skills, with the ability to identify root causes and implement corrective actions.

Strong computer skills, including proficiency in Microsoft Office Suite.

Ability to prioritize tasks and work effectively in a fast-paced environment.

Commitment to maintaining a high level of integrity and professionalism.

Education & Experience :

Bachelor's degree in a scientific or related field.

Previous experience in a quality assurance or quality control role, preferably in a regulated environment

Knowledge of change control processes, bill of materials management, and data regulated industry such as pharmaceuticals, medical devices, or food manufacturing.

Strong management systems experience (e.g., Oracle, SAP)

Familiarity with regulatory requirements and quality standards (e.g., FDA regulations, ISO standards).

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.