Sr Specialist, QC Systems Digital and Analytical Lab Solution

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. 

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality team.  As a Senior Specialist, Digital / CSV ( computer system validation ) and Analytical Equipment Management, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Model a culture of shared accountability, measurable impact and continuous evolution strategic planning
• Contribute to development and socializing of strategic, holistic roadmap with business and IT
• Works on problems of diverse scope requiring skilled analysis of the situation and/or data
• Facilitate stakeholder to prioritize initiatives, balancing fiscal responsibility and urgency
• Socialize and endorse IT governance and processes for discovery, prioritization, and planning
• Partner with IT peers to optimize solution, implementation, and support decisions/approaches
• Contribute to ensuring that IT applications, systems, processes, and personnel are implemented and operated in compliance with global regulations and standards (i.e., GxP, CFR, ICH, GDPR)
• Serves as the validation lead on cross-functional technology initiatives that involve multiple lines of business.
• Uses industry knowledge and best practices to develop validation strategies in harmony with the Quality Unit(s) and following processes that comply with regulations.
• Contributes towards the management and maintenance of processes/procedures defined in the system development lifecycle (SDLC) and Computer Systems Validation (CSV)
• Lead development of risk-based test strategies and plans for systems requiring validation and qualification, and mentor other staff as they develop project test strategies and plans.
• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence.
• Understand interdependencies between technology, operations, and business needs.
• Support equipment software updates and upgrades by writing/revising, executing, and reviewing software validation test scripts as needed.
• Take lead role and launch change control records for document and/or equipment changes.
• Perform data integrity and impact assessments for equipment and associated software.
• Computer and software configuration
• System /data backup solution configuration
• Routine system administration and ad-hoc issue resolution
• Complete equipment and software periodic reviews
• Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner.
• Coordinate with Facilities for scheduling calibration, maintenance, and repairs.
• A few hours of evening, weekend, and/or on-call work may be occasionally required to address equipment alarms.

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor's degree with at least 2 years of experience; OR a Master's degree with more than 0 years of experience; OR an Associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Experience in Quality administered systems
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
• Excellent communication and interpersonal skills
• Prior systems validation experience
• Previous experience working with change and configuration management systems
• Excellent written and oral communication skills
• Ability to proactively identify and implement continual improvements
• Ability to work effectively in a fast-paced team environment
• Ability to organize information in a consistent and readily retrievable manner
• Experience working with vendors
• Exceptional planning, coordination, and analytical skills