Experience: 6-8 years of experience in Quality Assurance / Quality control of sterile dosage manufacturing facility.

Core Competencies

Change Management processRisk assessments principles and toolsValidation of lab equipment’sDrug Product Process validationsRegulatory requirementsCompendial Changes

Technical Skills

Knowledge in validation principles and practices related to the Process validation, cleaning validation, Analytical Method validation, Water system, HVAC system, Equipment & Utility Qualifications.Knowledge of various Quality tools required for investigationsTechnical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organizationKnowledge in change control assessmentKnowledge on Chemical and Microbiology analysis.Basic idea on manufacturing operations, validation and engineering functionsExperience in handling Regulatory agency inspections

Behavioral/Any Other Skills

Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationshipManagerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills. Acts 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 objectivesSelf-accountable & Proactive approachCritical thinking and Compliance mindset

Core Responsibilities

Partially/fully independent, reviews critical change controls and protocols, trains others.Responsible for review & approval of documents as per current regulatory requirements.Assessment, approval & closure of change control and action itemsSite change review committee (SCRC) meeting with cross functional team to assess the change before initiation in gqts and present the critical change controls to the leadership team for its adequacy.Coordinating with CFT for addressing & resolving of Review Comments for timely Closure.Review & approval of Sops, Job aids, forms, Quality Risk Assessment (QRA), validation protocols, study protocols & summary reports.Review and approval of STP’s and specifications.Review and approval of stability compilation reports.Review and approval of APR’s.Review and approval of Environmental monitoring trends, Water monitoring trends, bioburden, BET, sterility trends, isolate trends and summary reports.Ensure manufacturing policies, procedures conform to PfizerReport any non-compliance to the ManagerExperience 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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