Senior Associate Quality Operations

Use Your Power for Purpose

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 team. You will be responsible for providing Quality Assurance support to GMP clinical manufacturing. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations to ensure compliance.
As a Sr. Associate, 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 explaining issues and create a collaborative team environment.
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
 

• Contribute to the successful execution of complex projects by managing priorities, meeting established timelines.

• Review and approve Good Manufacturing Practice (GMP/cGMP) records, including Drug Substance, Drug Product, Media Fill, investigations, and calibration out-of-tolerance documentation.

• Independently support Media Fill Program activities, including observation of personnel performing media fills to ensure compliance with aseptic practices, procedures, and regulatory standards.

• Review and approve Standard Operating Procedures (SOPs) and associated revisions to ensure compliance with applicable quality and regulatory requirements.

• Support the release of Drug Substance and Drug Product batches as required, in accordance with applicable procedures and quality standards.  

• Ensure all batch release documentation is reviewed for completeness, accuracy, and compliance with established procedures and regulatory requirements.

• Partner with manufacturing and support functions to identify, investigate, and resolve compliance issues in real time during manufacturing operations.

• Apply sound quality judgment to resolve moderately complex quality and compliance issues, seeking guidance from management or senior staff as needed.

• Assess and support compliance with internal procedures, regulatory requirements, and industry standards.

• Maintain and promote a continuous state of inspection readiness and participate in internal audits, customer audits, and regulatory inspections as required.

• Recognize quality, compliance, or operational risks that are beyond the scope of responsibility and promptly escalate concerns through appropriate channels.

• Participate and/or lead Limited Duration Teams (LDTs), Continuous Improvement (CI) initiatives, Corrective and Preventive Action (CAPA) programs, and effectiveness verification activities.

• Develop and support implementation of action plans to address quality observations, drive continuous improvement efforts, and ensure timely closure of assigned actions.

• Promote a culture of quality, compliance, patient safety, and Right First Time (RFT) execution.
   
   

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 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

• Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.

• Ability to work in a team environment within own team and interdepartmental teams.

• Excellent communication and interpersonal skills

• Proactive approach and strong critical thinking skills.

• Effective written and oral communication skills

• Experience with Digital Applications /Solutions