Preferred Education Qualification B Pharm M Pharm M Sc Experience 4- 6 years of experience in Quality Assurance MQA of sterile dosage manufacturing facility Core Competencies Technology Transfer Change Management process Risk assessments principles and tools Validation of manufacturing equipment s Drug Product Process validations Regulatory requirements Compendial Changes Technical SkillsFundamental knowledge on manufacturing and Quality control activities such as Solution preparation filling terminal sterilization visual inspection packing in process sampling and analysis Technical document review skills Knowledge in change control assessment Knowledge on manufacturing process such as stopper processing sampling and dispensing solution preparation Component Preparation Filling and Capping of Drug Product Behavioral Any Other SkillsActs Decisively Makes decision in a timely manner based on available information Grows Self Identify Individual development needs and create a plan and work towards achieving those objectives Critical thinking and Compliance mindset Core ResponsibilitiesGood performance partially independent reviews trends and data Responsible for review of Manufacturing documents such as SOPs Process validation cleaning validation cleaning process verification documents Batch manufacturing records Exhibit batch plan Exhibit batch Summary Reports study protocols and reports Tracking of change controls Providing QA Impact Assessment preapproval post approval closure of action items Coordinating with CFT for addressing resolving of Review Comments for timely Closure Review of product process related SOP Job aids Forms Review and approval of NVPC PH and conductivity Review and approval of APQR s Report any non-compliance to the Supervisor Work Location Assignment On Premise Pfizer is an equal prospect employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates Quality Assurance and Control LI-PFE