Current jobs related to Sr Associate Quality Compliance - Hyderabad, Telangana - Amgen
-
Sr Associate Quality Compliance
1 day ago
Hyderabad, Telangana, India Amgen Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCareer 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...
-
Prod Compliance Associate Sr, Brand Protection
2 weeks ago
Hyderabad, Telangana, India Amazon Full time US$ 90,000 - US$ 1,20,000 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 Supplier Quality
3 weeks ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionThe Sr Associate Supplier Quality position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen multi-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process...
-
Associate/Sr Associate
3 weeks ago
Hyderabad, Telangana, India Talodyn Networks Private Limited Full timeJob DescriptionPosition Associate/Sr Associate TaxLocation: Hyderabad / GurugramDepartment: TaxReports to: Tax ManagerJob Summary:We are seeking a detail-oriented and experienced U.S. Tax Preparer to join our growing tax team. The ideal candidate will be responsible for the accurate preparation of business tax returns (Forms 1120, 1120S, 1065, etc.) in...
-
Regulatory Affairs Sr Associate
1 week ago
Hyderabad, Telangana, India Amgen Full timeCareer Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure...
-
Sr Associate Field Effectiveness
2 weeks ago
Hyderabad, Telangana, India Amgen Full timeCareer Category Sales Sr Associate - Field Effectiveness Join 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...
-
Regulatory Affairs Sr Associate
1 week ago
Hyderabad, Telangana, India Amgen Full time ₹ 4,00,000 - ₹ 8,00,000 per yearThe Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable...
-
Sr. Associate IS Voice Engineer
3 weeks ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionDescriptionWe are seeking a motivated Sr. Associate IS Voice Engineer to join our team in India. This role involves designing and maintaining voice communication systems, ensuring optimal performance and reliability. Ideal candidates will have a passion for technology and the ability to troubleshoot complex issues in a fast-paced...
-
Sr Associate Digital Governance
3 weeks ago
Hyderabad, Telangana, India Amgen Full timeCareer Category Regulatory ABOUT AMGEN Amgen 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...
-
Hyderabad, Telangana, India Kreative Organics Full time ₹ 1,50,000 - ₹ 28,00,000 per yearWe are seeking a highly skilled Executive / Sr. Executive Quality Assurance with 8 to 10 years of experience in API / Bulk Drug Manufacturing. The role involves overseeing laboratory incidents, OOS/OOT investigations, analytical method validations, data integrity compliance, and ensuring adherence to GMP and regulatory standards.Key Responsibilities:Handle...
Sr Associate Quality Compliance
2 weeks ago
Role Name: Sr Associate Quality Compliance – Documentation Lead
Department Name: R&D Quality
Role GCF: 4
ABOUT AMGEN
Amgen 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 innovation, using technology and human genetic data to push beyond what's known today.
ABOUT THE ROLE
Role Description:
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 3-5 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.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
