Preferred Education/ Qualification :

B. Pharma / M. Pharma / M.Sc.

Experience : 1-5 years’ experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility.

Core Competencies : Fundamental knowledge of manufacturing process and quality oversight on Solution/Emulsion preparation and fill finish areas.

Role and Responsibilities:

Responsible for ensuring operating state of cGMP (current Good Manufacturing Practices) compliance in Solution/Emulsion preparation, vial/ampoule washing, Depyrogenation, Filling, Capping and Collection operations.

Maintain regulatory compliance in accordance with cGMP (current Good Manufacturing Practices) practices.

Ensure manufacturing policies and procedures conform to Pfizer standards.

Knowledge and hands on experience in reviewing eBR (Electronic Batch Record) and assessing the impact of AMPS (Agile Manufacturing Production System) exceptions with technical support/inputs from supervisor.

Review of batch reports and equipment audit trails.

Perform Alarm impact assessment, review and approval of trend reports. Ensure start-up and in-process activities performed as per batch record and compliance to Standard Operating Procedure.

Monitor and adherence manufacturing practices with respective standards and approved procedures.

Perform CCTV (Close Circuit Television) monitoring to oversight the activities in manufacturing process area.

Perform daily walk throughs as per clean room behavior/Coaching program and report observations to the supervisors and ensure appropriate closer of those incidents.

Review of daily NVPC (Non-viable Particle Count) workflow, Review and approval of trend report.

Report any non-compliance to the supervisor. Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.

AMPS:

Review and approval Master recipes.

Review and approval of Master workflows.

Review and approval of Master data (Graphs, Classes, Entities.).

  
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