Senior Associate Quality Complaints

2 days ago

Hyderabad, Telangana, India Amgen Inc Full time

What you will do

  • In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen.
  • In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements.
  • In addition, the team translates information from the market to drive continuous improvement.
  • The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation.
  • Evaluates and ensures triaged product complaint records align with applicable procedures
  • Evaluates and owns complaint records with basic investigations
  • Ensures quality of complaint records
  • Completes assigned assessments per applicable procedures
  • Applies analytical skills to evaluate sophisticated situations using multiple sources of information
  • Implements the complaint process per SOP requirements
  • Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
  • Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance

Basic Qualifications:

  • Masters degree and 1 to 3 years of Quality experience OR
  • Bachelors degree and 3 to 5 years of Quality experience OR
  • Diploma and 7 to 9 years of Quality experience

Preferred Qualifications:

  • Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
  • Bachelors Degree in a Science Field
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
  • Experience in driving decision making by using the DAI principles
  • Understanding of quality and industry requirements/expectations of a QMS
  • Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results
  • Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format

  • Senior Associate Quality Complaints

    4 days ago

    Hyderabad, Telangana, India Amgen Full time

    Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases....

  • Associate Quality Complaints

    2 days ago

    Hyderabad, Telangana, India Amgen Inc Full time

    *What you will do* In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging...

  • Associate Quality Complaints

    1 week ago

    Hyderabad, Telangana, India Amgen Full time

    Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases....

  • Manager Quality Complaints

    2 days ago

    Hyderabad, Telangana, India Amgen Inc Full time

    *What you will do* In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging...

  • Specialist Quality Complaints

    4 days ago

    Hyderabad, Telangana, India Amgen Full time

    Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases....

  • Senior Specialist, Specialty Complaints

    2 weeks ago

    Hyderabad, Telangana, India Synchrony Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    JOB_POSTING Job DescriptionRole Title: Senior Specialist, Specialty Complaints (L07)Company OverviewSynchrony (NYSE: SYF) is a premier consumer financial services company delivering one of the industry's most complete digitally enabled product suites. Our experience, expertise and scale encompass a broad spectrum of industries including digital, health and...

  • Senior Specialist, Specialty Complaints

    2 weeks ago

    Hyderabad, Telangana, India Synchrony Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Job Description:Role Title: Senior Specialist, Specialty Complaints (L07)Company Overview:Synchrony (NYSE: SYF) is a premier consumer financial services company delivering one of the industry's most complete digitally enabled product suites. Our experience, expertise and scale encompass a broad spectrum of industries including digital, health and wellness,...

  • Complaints Team Lead

    4 days ago

    Hyderabad, Telangana, India Wise Payments Full time

    Role Purpose:As a Global Complaints Team Lead at Wise, you will be instrumental in ensuring that our customers receive exceptional service and that their concerns are addressed promptly and effectively. Your primary purpose will be to execute a robust complaints management strategy that aligns with regulatory standards and supports our commitment to...

  • Senior Associate

    2 weeks ago

    Hyderabad, Telangana, India Newport Medical Solutions Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Senior Associate : SurgeryWe are looking for "Medical Coder" who can join us immediately. Below is the job requirement.Job Title: Senior Associate : Medical Coding - SurgeryYears of Experience: 2-3 yearsShift Timings: Day Shift (09:00 AM to 06:00 PM)Mode of operation: Work from officeMode of Interview: In-PersonLocation: Hyderabad, TelanganaExperience:2-3...

  • Senior Associate

    1 week ago

    Hyderabad, Telangana, India King Stubb & Kasiva Full time

    Senior Associate - LitigationPQE (Years of Experience) - 3-5QualificationsLLB / LLMJob DescriptionAbout the firm King Stubb & Kasiva is a Corporate Law Firm in India that has established teams in every practice area to ensure our services meet the most exact standards. They have their offices in Bangalore, Chennai, New Delhi, Mumbai, Kochi, Kolkata & Pune....