- Validation & Documentation: Lead all phases of computerized systems qualification and validation. You will review and approve validation packages, including Requirement Specifications, Design Specifications, Test Protocols, and Validation Summary Reports, ensuring compliance with regulatory requirements and internal standards.
- Deviation & CAPA Management: Serve as the primary QA contact for deviations and CAPA (Corrective and Preventive Actions), ensuring proper investigation and timely resolution. You will also initiate and manage deviations as required and act as a quality reviewer for problem records.
- Change Control & Audits: Initiate, implement, and track the completion of Change Control requests related to computer systems. You will also review and approve periodic system reviews and audit trail reports to ensure system integrity.
- Supplier & GxP Compliance: Provide support for supplier evaluations and oversee GxP Computerized Systems programs and projects. You will also participate in and support regulatory inspections as required.
- Process Improvement: Apply strong analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data to develop effective solutions. You will contribute to continuous improvement efforts and assist with training initiatives.
- A Master's degree with experience or a Bachelor's degree with extensive experience in Software and Systems Quality Assurance.
- A strong understanding of regulations such as 21 CFR Part 11, EU Annex 11, and GAMP standards.
- Proven experience in the validation of computerized systems and a strong application of GxP regulations (GMP, GLP, GCP, GPvP, GDP).
- Experience managing quality assurance processes, including Change controls, Deviations, and CAPAs.
- Familiarity with tools and systems such as HP ALM, Jira, Confluence, and TrackWise.
- Leadership: Strong leadership skills with experience leading projects, teams, or tasks.
- Problem-Solving: A demonstrated ability to handle and resolve complex quality issues using strong analytical and decision-making skills.
- Autonomy: The capacity to work independently with minimal supervision and drive tasks to completion.
- Collaboration: The ability to work closely with leadership and external experts to extend capabilities and enhance performance.
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What you will do · In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities throu ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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In this vital role, you will lead the execution of complex or novel validation assignments requiring strategic planning and development of new or improved validation techniques, deviations, and procedures. You will supervise validation activities, conduct internal audits, perform ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Roles & Responsibilities: · Review validation packages for completeness and compliance. · Approve documentation including protocols, plans, and traceability matrices. · Conduct data integrity assessments and periodic reviews. · Initiate and manage change control and deviations. · ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business ...
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We are seeking a Specialist Quality Complaints professional to join our Product Complaints and Surveillance team. In this critical role, you will be responsible for conducting complex complaint investigations, ensuring the quality of complaint records, and resolving corrective ac ...
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Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. · Evaluate complaints for severity and risk, ensuring timely review and processing. · Prioritize ...
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Job description · Role and Responsibilities: · Conducts quality review of telephonic/email conversations to ensure quality service goals and standards are met and/or identify areas where improvements can be achieved. · Audits sales outbound calls and/or correspondence, observing ...
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Blueberry Digital Labs is looking for a professional with a passion for excellence and a meticulous eye for detail to join our team as a Content Quality Control Specialist. In this role, you will be crucial to ensuring that all content meets our high standards for quality, accura ...
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Job description · We are looking for a motivated and passionate Senior quality specialist who is passionate about maintaining and upholding the quality of our creative deliverables such as - ad copies for multiple channels, animated videos, product demo videos, case studies, info ...
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Understand the current QA processes, tools, and technologies used within the organization. · Familiarize yourself with the product architecture, team structure, and ongoing projects. · Establish relationships with cross-functional teams to understand their expectations from your ...
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Hyderabad / Secunderabad, Telangana Full time5 days ago
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Key Responsibilities: · Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. · Verify correct inco ...
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Specialist - IT Quality - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited
Description
We are seeking a highly experienced and skilled Specialist - IT Quality to join our team in Hyderabad, India. In this critical role, you will be responsible for leading the execution of complex validation assignments and ensuring the compliance of our computerized systems. The ideal candidate will have extensive experience in Software and Systems Quality Assurance, a strong understanding of GxP regulations, and proven expertise in validation methodologies. You will serve as a key point of contact for deviations, change controls, and supplier management, playing a vital role in maintaining the integrity and compliance of our systems.
Responsibilities
Qualifications
Competencies
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Specialist - IT Quality
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Specialist - IT Quality
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Specialist - IT Quality
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Specialist Quality Complaints
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Specialist Quality Complaints
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Product Quality Specialist
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Specialist Quality Services
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Product Quality Specialist
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Content Quality control Specialist
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Specialist - Creative Quality Assurance
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Senior Specialist, Quality Assurance
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Periodic Report QC Reviewer
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Voice and Accent, Communications
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Senior Sourcing Specialist
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Periodic Report QC Reviewer
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