Associate Manager - MQA Downstream

Role Summary

The MQ TS Downstream Associate Manager is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.

Responsibilities

Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging 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 and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Team leader.

Review of Batch reports, and Equipment audit trails.

Hands on Inspector qualification and defect kit management activities.

Preferred Education/ Qualification

B. Pharm, M. Pharm, MSc.

Here Is What You Need (Minimum Requirements)

6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.

• Strong facilitation skills combined with instructional systems design experience
• Excellent interpersonal and communication skills to build and maintain effective working partnerships across all levels of the organization
• Proven ability to lead complex projects to successful outcomes
• Excellent computer skills, including proficiency in Microsoft Office Suite
• Ability to manage and assess vendors who develop and conduct training programs for the manufacturing team

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical industry experience
• Knowledge of current trends in training and organization development theory
• Experience in developing, delivering, and assessing classroom, computer-based, and competency-based functional training
• Strong analytical and problem-solving skills
• Strong organizational and time management skills
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Strong attention to detail and accuracy
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment: On Premise