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Sr Validation Engineer

4 weeks ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

- Roles & Responsibilities:
- Advising clients on how to meet compliance requirements using a risk-based approach.
- Develop validation documentation and standard operating procedures for various GxP applications.
- Develop test protocols that thoroughly test business requirements.
- Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements.
- Work with client business functions and domain experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
- Development of test / validation scripts based on software design and configurations.
- Develop IQ/OQ scripts as required.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

- Doctorate degree OR
- Master s degree and 4 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR
- Bachelor s degree and 6 to 8 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR
- Diploma and 10 to 12 years of Life Science / Biotechnology / Pharmacology / Information Systems experience

Preferred Qualifications:

Functional Skills:

Must-Have Skills:

- Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP
- Experience with regulatory agencies - FDA, EMEA, CFDA, and other regulatory agencies
- Proven leadership skills with the ability to multitask and lead multiple validation projects
- Thorough understanding of the principles of GAMP, SDLC methodologies and testing standard methodology.
- Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
- Expertise with ALM testing and ALM software (HP)
- Expertise in use - Veeva (all modules - CDocs, QMS, RIM, DocuSign, etc)
- Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
- Good-to-Have Skills:
- Ability to work independently, excellent problem solving and professional written communications skills.
- Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus
- FDA Audit experience a plus & working with regulatory agencies
- Experience with enterprise CDS platform software (Empower/Chromeleon/Unicorn)
- Soft Skills:
- Excellent leadership and team management skills.
- Strong transformation and organizational change experience.
- Ability to work effectively with global, virtual teams.
- Excellent analytical and solving skills.
- Ability to prioritise successfully.
- Strong presentation and public speaking skills.
- Strong verbal and written communication skills.
- High degree of initiative and self-motivation.