Sr. Associate Quality Compliance

4 days ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 24,00,000 per year

The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system.

Roles & Responsibilities:

  • Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards.
  • Track documentation milestones and follow up with contributors to ensure deadlines are met.
  • Provide in-depth technical editing and proofreading support to maintain consistency with approved templates and formatting standards.
  • Conduct rigorous Q checks to ensure all documents meet regulatory, procedural, and formatting requirements.
  • Maintain and update controlled document templates and ensure consistent application across documents.
  • Support audits and inspections through documentation readiness activities.
  • Collaborate with cross-functional teams to execute document-related tasks and resolve workflow issues.

Basic Qualifications and Experience:

  • Masters Degree in Sciences or related field with 5-9 years exp in Pharmaceutical/Biotechnology/Clinical research

Functional Skills:

Must-Have Skills:

  • Strong project management skills including milestone tracking and workflow oversight.
  • High proficiency in technical editing and document formatting.
  • Familiarity with regulatory documentation in a GCP or similar environment.
  • Experience with document management systems and inspection readiness.

Good-to-Have Skills:

  • Experience working in a multinational environment with global teams.
  • Proven ability to manage multiple documents simultaneously while maintaining high quality.

Soft Skills:

  • Excellent verbal and written communication skills.
  • Strong problem-solving abilities and adaptability to changing priorities.
  • Strong attention to detail and accuracy.
  • Excellent organization and coordination skills.
  • Clear and concise communication abilities.
  • Team-oriented and proactive approach.

  • Sr Associate Quality Compliance

    14 hours ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Career CategoryQualityJob DescriptionSr Associate Quality ComplianceRole Name: Sr Associate Quality Compliance – Process ModelerDepartment Name: R&D QualityRole GCF: 4ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and...

  • Prod Compliance Associate Sr

    1 week ago

    Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    "Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon."Job Description is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Brand Protection Business Operations team as a Prod Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a...

  • Sr Associate Quality Compliance

    10 hours ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Career CategoryQualityJob DescriptionRole Name: Sr Associate Quality Compliance – Documentation LeadDepartment Name: R&D QualityRole GCF: 4ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines...

  • Sr. Associate, Quality Compliance

    1 week ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Role Description:The senior associate will work within R&D Qualitys Business Intelligence and Data Analytics (BIDA) team to help deliver actionable information and recommendations to key leaders and stakeholders by maintaining and expanding our data pipelines, tools, and reporting. This role contributes to ensuring Amgens pursuit of life-saving medication is...

  • Sr. Associate, Quality Compliance

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of...

  • Prod Compliance Associate Sr, Selection Validation

    1 week ago

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

    ***"Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon" **** is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Selection Validation team as a Product Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a training ground for...

  • Prod Compliance Associate Sr, Selection Validation

    1 week ago

    Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    DESCRIPTION***"Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon" **** is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Selection Validation team as a Product Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a training...

  • Sr Associate Supplier Quality

    3 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving Patients At 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....

  • Sr. Associate

    16 hours ago

    Hyderabad, Telangana, India Sutherland Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company Description Sutherland is seeking a strategic-thinking and dynamic person to join us as Sr. Associate - Impl_DES. We are a group of driven and energetic individuals. If you are looking to build a fulfilling career and are confident you have the skills and experience to help us succeed, we want to work with you  Job DescriptionExceptional...

  • Senior Associate, Research and Development Quality Compliance

    1 week ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Senior Associate, Research and Development (R&D) Quality Compliance Career CategoryQuality Job DescriptionSupports the R&D Quality (RDQ) Compliance Managers in the following areas:Input of audit responses into QMS Input of site inspection data into the Inspection Management System Working with deviation owners to ensure the timely development...