Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight.

Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of company's mission globally.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

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

How You Will Achieve It

• ROLE RESPONSIBILITIES

• Performs tasks to facilitate the Site Training Programs.
• Performs document control functions, including admin training login accounts, generation, tracking, processing, review, distribution, release and archiving of documents.
• Coordinates the revision, review, and approval of documents in the PLS systems.
• Organizes and ensures accurate and reliable filing of all paper-based documents as well as electronic copies (e.g., MSB Digital Signature).
• Site Point of contact for Training during corporate and FDA audits. 
• Site Point of Contact for writing investigations involving the Training department.
• Maintains processes for SOPs, master batch records, specifications, test methods, OJTs, validation protocols/reports, technical protocols, reports, and other GMP documents.
• Monitor and provides follow up with department meetings on document target completion dates for the Periodic Review Program.
• Maintains and distributes SOP, Forms, and logbook reconciliation for all departments.
• Assists in the Annual Curriculum Review for site.
• Completes continuous improvement and project work for documentation and training systems.
• Provides support for Training systems for regulatory, corporate, and vendor audits.
• Reports training metrics for the site’s monthly Site Quality Review Team/Management Review meeting.  Will monitor metrics to ensure they meet site metric goal. Will take actions from Site Quality Review Team and monitor actions to completion. 
• Will determine updates to training SOPs and SOJTs and train other colleagues in the department on changes.
• Conduct gap assessments on site standards, policies, and procedures to ensure they are aligned with global Pfizer Quality Standards.
• Author and revise various quality documentation (SOPs, CAS Reports, Change Controls, CAPAs/Commitments, Risk Assessments, etc.) in QTS system.
• Role will require after hour and weekend support from time to time.

Qualifications

Education: 

• Applicant must have High School Diploma with eight years of relevant experience; OR an associate degree with six years of experience; OR a bachelor’s degree with at least three years of experience; OR a master’s degree with more than one year of experience. 

Experience:  

• Must be skilled in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat.
• Must be well-organized and have the ability to maintain attention to detail while executing multiple tasks
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
• Ability to effectively build and maintain relationships, communicating and interacting with multiple departments.
• Managing timelines to meet corporate goals.
• Demonstrated ability to work in a productive and collaborative cross-functional manner.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.