Preferred Education/ Qualification : B. Pharm/M. Pharm/M.Sc.

Experience : 6 – 8 years of experience in Quality Assurance / MQA of sterile dosage manufacturing facility /Technology Transfer/Validation.

Core Competencies :

Technology Transfer of injectablesChange Management processRisk assessments principles and toolsValidation of manufacturing equipment’sDrug Product Process validationsRegulatory requirements Compendial Changes

Technical Skills :

Fundamental 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 skillsKnowledge in change control assessmentKnowledge on manufacturing process such as stopper processing, sampling and dispensing, solution preparation, Component Preparation, Filling and Capping of Drug Product.Should be capable of handling regulatory inspections USFDA/MHRA/TGA, etc.,

Behavioural/ Any Other Skills:

Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationshipActs Decisively: Makes decision in a timely manner based on available informationGrows Self: Identify Individual development needs and create a plan and work towards achieving those objectivesCritical thinking and Compliance mindset.

Core Responsibilities :

Good performance, partially independent, reviews trends and dataResponsible 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 SupervisorShould have trouble shooting abilities in manufacturing   Quality 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.

Experience in handling regulatory, corporate and internal auditors/ inspectors.

  
Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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