About this role
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
This role acts as Independent Quality reviewer and approver of Computer Software Validation documentation . As a member of the Digital Quality Assurance team, this role works closely with the Project team and the Validation team to ensure West procedural and regulatory requirements are met throughout the Computer System lifecycle of GxP Computer systems.
Essential Duties and Responsibilities
- Oversee GxP projects assigned and ensure all the computer system Validation activities are in line with West QMS and regulatory requirements.
- Review and approve Computer System Validation lifecycle documents.
- Provide inputs during GxP assessment and Risk assessment from QA perspective.
- Participation in projects meeting and provide guidance to project team and Validation team towards CSV activities.
- Follows West procedures on Computer System Validation, sup ports the validation of GxP software and process improvements to software.
- Works closely with Project team to document regulatory requirements for GxP applications.
- Reviews Test Protocols/evidence, executions and execution deviations as applicable.
- Review and approve Computer software change control documentation.
- Provide training to Digital & Transformation team on CSV process.
- Assist the Digital QA lead during Internal/External audits on the QMS documentation.
- Involve, preparation, review and approval in documentation related to Digital quality.
- Assist in CSV procedure/work instruction creation, review and approval.
- Participation in Global quality events.
Education
- Education: Batchelor or master’s degree in science related field, or Information Technology
Work Experience
- Experience: 3-6 years
Preferred Knowledge, Skills and Abilities
- Regulatory requirements for ERES like FDA 21 CFR Part 11, Eu Annexure 11 etc.,
- End to End Computer System Validation process.
- Risk Management
- Exposure to Computer Software Assurance approach
- Agile and Waterfall Methodology
- Ability to work in a team environment and under guidance.
- Audit process
- Incident, Deviation and CAPA process knowledge
- Exposure to AI based Computer Systems.
- Periodic review
Travel Requirements
10%: Up to 26 business days per year
## Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
## Shift
- Prefer 12pm – 9pm India time. Willingness to work outside of these hours as needed.
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.