▷ (15h Left) Quality Assurance Principal Associate

2 days ago


Hyderabad India Lilly Full time

Job Description Position Brand Description: Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The PIP (person in plant) API EM Quality Assurance Principal Associate will provide support to all quality activities within a dynamic external manufacturing environment. The PIP position is based in Hyderabad, India with travel as required to Visag. The candidate must be within commute distance. The QA Associateu2019s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. The QA Associate will need to interact daily with a wide variety of people, primarily external partners team members and site management. Key Objectives/Deliverables: - Serve as a liaison between CMs and Lilly. - Provide quality oversight of CMs including being the initial point of contact for all quality related issues. - Escalate quality issues at CMs to Lilly QA management. - Assist in the establishment and revisions of Quality Agreements with affiliates and customers. u2022 - Provide quality oversight of Lilly/APIEM Quality Plans - Coordinate and perform QA responsibilities of API shipments. - Participate in regulatory inspection preparations with CMs. - Provide on-site support during manufacturing events and inspections. - Participate on the Technical Review Board - Evaluate and disposition API batches, if required. - Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. - Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures. - Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable. - Ensure all processes are in an appropriate state of control. - Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product. - Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, and computerized system validations. - Participate in APR activities. - Participate in projects to improve productivity. - Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams. Basic Requirements: - Bachelor of Science in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. - Previous GMP manufacturing experience in API manufacturing in a Quality Assurance role (minimum 5 years of GMP QA on the floor support) - Minimum 10 years of experience in a Quality Assurance role in u201Cbig pharmau201D as the Market Authorization Holder for non-generic products. - Demonstrated foundational knowledge of ICH and EMA regulations. - Experience participating in internal, customer, and regulatory inspections - Process Validation and Technical Transfer experience - Fluent in English Additional Preferences: - Demonstrated coaching and mentoring skills. - Experience in root cause analysis. - Demonstrated application of statistical skills. - Demonstrated strong written and verbal communications skills. - Strong attention to detail. - Proficiency with computer system applications. - Excellent interpersonal skills and networking skills. - Ability to organize and prioritize multiple tasks. - Ability to influence diverse groups and manage relationships. Education Requirements: - BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. u2022 - Master of Science preferred Other Information: Other Information: - Must complete required training for API EM Quality Assurance. - No certifications required. - Required onsite 2-3 days a week and must be able to support 24 hour/day operations. - Some travel ( 25%) is required primarily to Vizag Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lillyu00A0does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly



  • Hyderabad, Telangana, India Eli Lilly Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Hyderabad/ Secunderabad, India Eli Lilly And Company Full time ₹ 10,00,000 - ₹ 25,00,000 per year

    Job Description At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...


  • Hyderabad, India Kofax Full time

    Management and staff in Tungsten Automation's Quality Assurance job family help the company to assure that its products and technology solutions are designed and built in accordance with company standards and customer requirements.  Responsibilities of the Principal Engineer position include: Responsible for larger or more complex departmental work,...


  • Hyderabad, Telangana, India Tungsten Automation Full time US$ 1,00,000 - US$ 1,50,000 per year

    ResponsibilitiesManagement and staff in Tungsten Automation's Quality Assurance job family help the company to assure that its products and technology solutions are designed and built in accordance with company standards and customer requirements. Responsibilities of the Principal Engineer position include:Responsible for larger or more complex departmental...


  • Hyderabad, Telangana, India Thomson Reuters Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Join our team as an Associate Quality Assurance & E-file Analyst, where you'll play a crucial role in ensuring the quality and performance of our tax-related products. You'll leverage your expertise in accounting and tax preparation, along with your analytical skills, to evaluate product designs and processes from a customer-centric perspective, while...

  • Quality Assurance

    1 week ago


    India Zensar Technologies Full time

    **What's this role about** Associate will enable projects to follow standard lifecycle frameworks, review their processes implemented and perform sample checks, carry out risk based assessments, publish reports, support team on quality assurance. Facilitate improvements and corrections as and when necessary. **Here's how you'll contribute**: You'll do...


  • Hyderabad, Andhra Pradesh, India Adani Enterprises Ltd Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Associate Lead - Quality Quality Assurance Support: Assist in executing quality assurance processes across project sites. Ensure compliance with engineering standards by conducting inspections and reporting deviations.Quality Control Assistance: Support the monitoring of construction quality during project execution, ensuring adherence to established...


  • Gurugram, Gurugram, India MobiKwik Full time

    Job Description Mobikwik is India's leading Digital Financial Services platform & Largest Digital Wallet, trusted by over 167 million users & 4.4 million businesses. As a pioneer in the Fintech space, Mobikwik empowers its users with a robust suite of services, including Digital payments, Credit & Investments. Recently, Mobikwik achieved a significant...


  • India TerraFinn Technologies, Mumbai Full time

    Company Name: Terra Finn Technologies Website: Client: Fitch Ratings Website: Salary: 25+ lacs Mode: Full-time, remote Experience: 6+ Years Joining: Immediate  Lead/Senior Quality Assurance   About the Role We are seeking a highly skilled Automation QA Engineer with expertise in AI-driven testing to join our quality engineering team. The...

  • Quality Assurance

    2 weeks ago


    India Jupiter AI Labs ✔ Full time

    About the Role: We are looking for an experienced Quality Assurance Consultant to oversee quality checks for product batches before export. The role involves close coordination with accredited labs, suppliers, and internal teams to ensure compliance with quality standards and regulatory requirements. Key Responsibilities: - Coordinate with NABL-accredited...