Associate Manager - Quality

Role Summary :

The MQA Upstream Associate Manager is responsible for ensuring Solution / Emulsion preparation, Vial / Ampoule washing, Depyrogenation, Filling, Capping and Collection areas of production & monitor process for compliance to cGMP (current Good Manufacturing Practices) standards.

The MQA Upstream Associate Manager is directly responsible for managing and coordinating all quality functions within the area. Capping and Collection

This individual must also work with cross functional teams.

Roles and Responsibilities :

• Responsible for ensuring operating state of cGMP compliance in Solution / Emulsion preparation, vial / ampoule washing, Depyrogenation, Filling, Capping and Collection operations.
• Maintain regulatory compliance in accordance with cGMP 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.
• Perform equipment breakdown assessments and ensure product quality and patient safety independently.
• Report any non-compliance to the supervisor.
• Responsible for performing manufacturing investigations, implementation and approved investigation CAPA
• Manage investigation and apply relevant and necessary actions / systems to ensure appropriate closure of those incidents.
• 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.
• Experience in handling regulatory, corporate and internal auditors / inspectors.
• Responsible for assisting manufacturing investigators for collection of data, information and technical support and may perform in conducting investigations.
• Ensure that reports are aligned with regulatory requirements, site standards procedures and company policies.
• May lead a team of MQA colleagues on an interim basis in the absence of the Supervisor.
• Review and approval Master recipes, Master workflows. & Master data (Graphs, Classes, Entities.)

Minimum requirement :

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

Skills Required

Regulatory Compliance, Capa