QC Supervisor

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

Job Overview

The QC Supervisor focused on the Quality Control Laboratory, offering project and task management along with technical leadership. The incumbent is tasked with ensuring QC testing is conducted in accordance with established procedures and guidelines. Moreover, they are entrusted with providing training, facilitating development, and offering necessary resources, information, and guidance. The QC Supervisor assumes responsibility for managing and coaching team members. Leveraging their technical expertise and knowledge of pharmaceutical testing, including critical issues related to test methods, laboratory instrumentation, and operational principles, as well as staying updated on current regulatory guidelines, they ensure the safe, efficient, and effective functioning of laboratory operations. This role plays a crucial part within the QC department, ensuring that team activities comply with relevant rules and regulations, such as current USP-NF, cGMP, safety protocols, in-house SOPs, and testing procedures.

QUA

Responsibilities

• Leading a quality control team and managing associated lab focused on Aurolife Unit-2.
• Planning, organizing, and scheduling activities based on business needs.
• Supervise Daily Operations: Oversee the quality control department's day-to-day operations.
• Responsible for Data Integrity compliance and laboratory GLP/cGMP/GxP compliance
• Ensuring the accuracy of analytical measurements and compliance with cGMP, US FDA, and other regulatory and corporate requirements.
• Conducting troubleshooting and investigations using critical thinking skills and creativity in problem-solving.
• Overseeing analytical method transfers and method verifications.
• Preparing and reviewing Test Procedures, SOPs, Protocols, and Reports.
• Reviewing analytical data generated in the laboratory for accuracy and adherence to documentation requirements. Compiling data and trend summaries for regulatory submission.
• Communicating and coordinating activities with other departments such as manufacturing, Quality Assurance, and R&D.
• Providing status updates to management and promptly communicating any observed technical or scheduling problems.
• Taking the lead on special tasks assigned by management is expected.
• Preparing for internal and external audits such as preapproval, cGMP, and post-approval inspections by USFDA are significant responsibilities.
• Other tasks as assigned.

Qualifications - Skills & Requirements

• Minimum of 8 to 10 years of experience in the pharmaceutical industry, preferably with 3 to 5 years of experience in drug device combination product pharmaceuticals.
• Experience in release and stability testing of metered dose inhalers, Transdermal and Topicals, including chromatographic and product performance testing. Relevant experience should include tests such as aerodynamic particle size by cascade impactor, dose content uniformity, spray pattern, moisture content, assay and impurities, and excipient content. Transdermal physical and chemical testing.
• Knowledge and experience in method transfer and validation, with prior supervisory roles being advantageous.
• Familiarity with pharmaceutical regulatory standards, including USP/ICH/FDA 21 CFR 210/211, CFR 11 & CFR 820/ISO 13485/cGMP/safety etc.,
• Experience in leading a team and managing a lab in a fast-paced environment.
• Expert organizational and project management capabilities. Strong oral and written communication skills.
• Desirable knowledge or experience with specialty products like Transdermals, Topicals, Inhalations.

Education & Experience
Minimum BS with Scientific field BS with Chemistry is one of the subjects would be preferable Minimum 5-8 years experience in pharmaceuticals. Should have at least 3-5 experience with generic pharmaceuticals. More QC experience in generic pharmaceuticals industries would be an added advantage Knowledge in Method Development & Method Validation would be preferable and previous supervisory experience would be added advantage Up-to-date knowledge in USP/ICH/FDA /cGLP/cGMP/Safety regulations would be added advantage Experience handling and testing Control Substances would be preferable Ability to learn quickly & Train team members Technical, Administrative, Decision making, Communication skills and Ability to work under pressure Knowledge in operating the LIMS would be preferable

Physical Requirements

LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk. Must practice good personal hygiene Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting
Additional Physical Requirements

Lifting 8+ Hours - 0-10 PoundsSitting 1-4 HoursBending 1-4 HoursStanding 4-8 HoursWalking 1-4 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.