Senior Validation Specialist

Senior Validation Specialist

Introduction to role

Are you ready to lead and innovate in the world of GxP compliance? As a Senior Validation Specialist, you will provide GLP and GCP compliance support to the Integrated Bioanalysis (iBA) Department. You will spearhead the GxP system validation program and manage the life cycle of systems including instruments, equipment, and software within our Regulatory Bioanalysis Lab.

Accountabilities

• Lead instrument/system validation programs. Schedule and coordinate cross-functional activities among internal stakeholders and external vendors to support instrument/equipment/system validation.

• Manage the life cycle of validated instruments/equipment and systems by working with internal stakeholders from conception, understanding the requirements, Capex request, through development, release for operational use, to system retirement.

• Generate validation documents, execute protocols/temperature mapping, QC documents/data and write validation reports.

• Routinely review instrument logbooks, service records and other documentations required per GxP.

• Author, review and route SOPs, Quality Issues, CAPAs and other documents for approval in support of quality systems.

• Sustain system validation expertise and leadership in support of the GxP operations within iBA.

• Actively participate in maintenance, improvements and implementation of quality systems and tools supporting GxP compliance.

• Aid in the QC of laboratory data and reports when needed.

Essential Skills/Experience

• Bachelor’s or Master’s degree in science or a related field with 3+ years of experience in the biopharmaceutical/pharmaceutical industry in a Compliance or Equipment/System validation related role

• Strong written communication skills, including background authoring documents in support of regulatory compliance (SOPs, validation documents, etc)

• Excellent verbal communication and interpersonal skills, including ability to forge strong relationships and influence stakeholders across business disciplines

• Strong organizational and analytical skills, including prioritization and time management. 

• Ability to adapt to changing business priorities and challenges

• Professional and highly detail oriented

• Proficient with MS Office (Word, Excel, Visio, Project)

• Knowledge of GLP regulations and GxP system validation

• Expertise in Quality, operational and compliance management

• Ability to work well with others and contribute effectively to a team

Desirable Skills/Experience

• Experience with Veeva Vault is a plus

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we thrive on tackling unknowns and embracing change. Our dynamic environment allows us to take calculated risks and make bold decisions that can change patients' lives. We are dedicated experts who combine specialist knowledge with curiosity, always searching for better ways to achieve the best results. Our collaborative approach ensures that we leverage diverse perspectives to improve impact. Here, you will have countless learning opportunities and the chance to make a profound impact on society and patients worldwide.

Ready to make a difference? Apply today!

The annual base pay (or hourly rate of compensation) for this position ranges from $96,388 to $144,583. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.