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Amgen Inc
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GCP Quality Compliance Manager

GCP Quality Compliance Manager

Amgen Inc

6 - 10 years

7 - 11 Lacs

hyderabad

Posted:12 hours ago| Platform:

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Skills Required

r lanuage root cause analysis biotech knowledge management natural language processing quality management risk analytics data quality project management quality improvement gcp data analytics quality assurance monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

What you will do

Lets do this! Lets change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgens R&D Quality Management System (QMS).

Accountabilities:

Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements.
Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for continuous improvement.
Provide hands-on support to the Senior Manager in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D.
Act as a liaison between the Process Quality function and Global Networks supporting smooth collaboration and exchange of information.
Provide support for Serious Breach Process
Perform risk assessments of process, vendors and functions
Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions
Coordinate activities related to site/sponsor inspections and audits - preparation, conduct and close out and response generation

Key Capabilities:

Understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&D environment
Communicate effectively
Develops innovative and creative output based on interpretation and analysis
In-depth disciplinary knowledge; uses business insight and subject matter expertise
Employs project management techniques
Thorough understanding of business priorities, strategy and direction
Integrates trends, data and information into plans, deliverables and recommendations
Manages root cause analysis and corrective/prevent action completion follow-up
Acts as a technical expert in GCP
Employs critical thinking skills
Able to separate critical from non-critical issues
Strong attention to detail and proficiency in managing data and reports.
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methodsleveragingAI and Natural Language Processing, and other advanced data analytics methods).

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills and has these qualifications.

Basic Qualifications:

Doctorate degree OR
Masters degree and 2 years of Quality/Compliance/Process Management experience OR
Bachelors degree and 4 years of Quality/Compliance/Process Management experience OR
Associates degree and 8 years of Quality/Compliance/Process Management experience Or
High school diploma / GED and 10 years of Quality/Compliance/Process Management experience

Preferred Qualifications:

2 years or more experience in
Quality Management
,
Quality Assurance
, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.
Solid understanding of SOP/Standards management and methods/ technology used to drive knowledge management
across a diverse R&D environment.
Thorough understanding of
Clinical R&D activities and Global Regulations.
Strong analytical, critical thinking, and decision-making abilities.
Strong Process Mind and analytically oriented -
experience with process monitoring, including applying analytical methods and modern technology to enable signal detection and quality improvement.
Proven team player
takes direction and can rapidly learn and support a hard-working team, making rapid decisions and communicating them promptly.
Excellent verbal and written communication skills
- demonstrates strong business writing abilities and active listening.
Capability to understand and articulate technical concepts and literature in
spoken and written English.

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Amgen Inc

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GCP Quality Compliance Manager

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

What you will do

Accountabilities:

Key Capabilities:

What we expect of you

Basic Qualifications:

Preferred Qualifications:

Quality Management

Quality Assurance

Solid understanding of SOP/Standards management and methods/ technology used to drive knowledge management

Clinical R&D activities and Global Regulations.

Strong Process Mind and analytically oriented -

Proven team player

Excellent verbal and written communication skills

spoken and written English.

More Jobs at Amgen Inc