AstraZeneca Pharmaceuticals LP Validation Documentation Specialist - Mt. Vernon - Global Operations in Mount Vernon, Indiana

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Validation Documentation Specialist in Mt. Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.

The Validation Documentation Specialist is responsible for the deployment, operation, and Mt Vernon administration of the Validation Lifecycle Management System (paperless Validation platform) and Validation department physical documentation (protocols, reports, technical papers, etc.) tracking, storage, and archival. The role additionally supports delivering the manufacturing batch record change processes for the US Mount Vernon site.

The Validation Documentation Specialist further supports Validation department activities through document collection, processing, and data entry in support of Cleaning Validation, Qualification, and Continued Process Verification. The role also serves as a site backup for Learning Management System and Light Document Management System.

Responsibilities:

  • Serves as superuser and site lead for Validation Lifecycle Management System (paperless Validation platform) deployment, operation, and Mt Vernon administration.

  • Processes cGMP documents in complex, automated document management systems such as LDMS (Light Document Management System). Coordinates review and approval of documentation by subject matter experts. In scope documents include but are not limited to: Drug Product Master Batch Records, Standard Operating Procedures, Test Methods, Forms, and other cGMP documents.

  • Manage electronic documentation throughout the entire life cycle in accordance with business requirements and records retention policies.

  • Maintains Validation department physical documentation (protocols, reports, etc.) tracking, filing, archival, and retrieval. Ensures an accurate record of physical documents is maintained.

  • Provides backup support Learning and Development department: Performs Learning Management System (LMS) Administration activities including data entry, on-line course creation, curricula development, and reporting functionality.

  • Supports Validation department operations through document collection, processing, and data entry in support of Cleaning Validation, Qualification, and Continued Process Verification. This includes data entry, verification, or retrieval from physical paperwork, Microsoft Excel spreadsheets, LIMS, Biovia Discoverant, and other software platforms.

  • Furnishes data and support for internal and regulatory agency audits and inspections.

Qualifications:

Education:

  • Bachelor’s degree or 4 years of relevant industry experience.

Required:

  • A minimum of 2 years experience in electronic document management, data management or MRP systems.

  • Knowledge of cGMP requirements, compliance, validation

  • Experience using personal computers and database computer system applications.

  • Strong interpersonal and communication skills with the ability to work across all levels of the company.

  • Strong organization skills and ability to support multiple projects simultaneously.

  • Demonstrated high-level of attention to detail.

  • Strong project management skills and experience.

Desirable:

  • Technical Document Management and change management experience.

  • Knowledge of pharmaceutical validation life cycle and associated deliverables

  • Proven ability to work independently and professionally in a GMP-regulated environment.

  • Experience with Biovia Discoverant

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.