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 AchieveYou will be a member of Pfizers dedicated and highly effective quality assurance team. You will evaluate and review Pfizers clinical and commercial batches of drugs. 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 and change control activities to ensure compliance with configuration management policies.As a Senior 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 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 ItResponsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.Maintain regulatory compliance in accordance with cGMP practicesEnsure manufacturing policies and procedures conform to Pfizer standardsKnowledge and hands on experience in reviewing EBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Specialist or Supervisor.Review of Batch reports, and Equipment audit trailsPerform Acceptable Quality level sampling, Inspection and record the resultsin Batch records for all productsPerform batch start:up and end activities viz. sensor challenge tests, recipe review etc.Perform random process checks for Terminal Sterilization, Visual Inspection and PackagingPerform Daily walkthroughs and report observations to the Supervisor.Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Specialist or Supervisor.Review and assessment of equipment alarms and review of quarterly alarm trends.Report any non:compliance to the SupervisorShould have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime and increase the Efficiency.Responsible to act as shift supervisor in absence of shift lead**Qualifications**:Must:HaveBachelors Degree8+ years experienceKnowledge of current Good Manufacturing Practices and the applicable GxP regulations and standardsProactive approach and strong critical thinking skillsMust be able to work in a team environment within own team and interdepartmental teamsExcellent communication and interpersonal skillsGood working knowledge of Microsoft Excel and WordNice:to:HaveMasters degree and relevant pharmaceutical experienceWilling to lead by example and jump right in, desire to get to root cause, collaborative and active listenerEffectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressurePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and ControlYou must create an Indeed account before continuing to the company website
