Sr Quality Engineer

Amgen; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Benefits offered by this job

Comprehensive Total Rewards Plans

Support for professional growth

Job summary

Amgen in Hyderabad is looking for a Quality Engineering representative to ensure compliance with global regulations in product development. The ideal candidate will oversee quality processes for various products, provide technical expertise, and serve as a key contact for quality assurance.

This position requires strong experience in quality management, preferably within the biotech or pharmaceutical industry, and the ability to train teams on combination product standards. Amgen supports professional growth through competitive rewards and benefits.

Qualifications

• Master’s degree with 7 to 10 years of Quality experience or Bachelor’s degree with 9 to 13 years of Quality experience.
• Experience in biotech or pharmaceutical industry is preferred.
• Ability to oversee multiple medium complexity projects.

Responsibilities

• Provide Quality technical expertise and serve as a single point of Quality contact.
• Ensure program alignment within Design and Development Plans.
• Train and educate partners on combination product requirements.
• Contribute to regulatory submissions and support audits.

Skills

Quality engineering principles

Risk management

Human Factors Engineering

Project management

Negotiation skills

Education

Bachelor’s degree

Master’s degree

Job description

Let’s do this. Let’s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company’s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards.

Responsibilities

• Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities.
• Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs.
• Train and educate key functional partners and management on combination product requirements, standards and regulations.
• Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs.
• Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on‑body injector systems, and accessories.
• Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging.
• Provide independent design review for other programs.
• Provides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selection.
• NOTE: This role may require working in shifts or extended hours within the same shift.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications.

Basic Qualifications

• Master’s degree and 7 to 10 years of Quality experience OR
• Bachelor’s degree and 9 to 13 years of Quality experience

Preferred Qualifications

• 7+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
• Degree in a Science Field
• Ability to oversee multiple medium complexity projects simultaneously
• Working knowledge of quality engineering and/or mechanical engineering
• Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
• Prior experience working as part of a combination product launch team
• Able to successfully manage workload to meet timelines
• Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience driving decision making by using Decision, Advice and Inform (DAI) principles
• Understanding of industry requirements/expectations of a Quality Management System (QMS)
• Understanding of the applicable manufacturing/testing processes (i.e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations
• Comfortable with both drug and device terminology
• Ability to travel +/- 15-20% of time to domestic and international Amgen sites

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.