Leads manufacturing quality assurance for terminal sterilization, visual inspection, and packaging operations. Ensures cGMP and Pfizer policy compliance, reviews electronic batch records, batch reports, equipment audit trails, and exception impacts, and manages inspection qualification and defect kits. The role also supports training programs, vendor management, complex projects, and cross-functional partnerships in a pharmaceutical manufacturing environment.
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.
Bonus Points If You Have (Preferred Requirements)
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Manufacturing
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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Manufacturing
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports pharmaceutical manufacturing by operating production equipment, preparing materials, maintaining inventory, following standard procedures and cGMP requirements, performing in-process quality inspections, solving routine problems, and contributing to safety and process improvements. Works collaboratively, manages assigned tasks with moderate supervision, and ensures work meets accuracy and quality standards.
Top Skills:
Cgmp
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports pharmaceutical manufacturing compliance through document management, electronic form conversion, audit response preparation, change control coordination, CAPA and CCF tracking, manufacturing walkthroughs, and process improvement. The role collaborates with cross-functional teams to ensure documentation readiness and timely inspection preparation while maintaining compliance with cGMP requirements.
Top Skills:
CgmpPdocsSAPSds
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Leads quality oversight for sterile injectable manufacturing, ensuring cGMP compliance, regulatory readiness, documentation accuracy, batch record review, SOP approval, investigations, CAPA effectiveness, audits, and continuous improvement. Manages quality personnel, partners with production operations to resolve compliance issues, and supports inspection and corporate quality standards.
Top Skills:
CgmpChatgptEmpowerLaboratory Information Management Systems (Lims)Microsoft CopilotMS Office
What you need to know about the Bengaluru Tech Scene
Dubbed the "Silicon Valley of India," Bengaluru has emerged as the nation's leading hub for information technology and a go-to destination for startups. Home to tech giants like ISRO, Infosys, Wipro and HAL, the city attracts and cultivates a rich pool of tech talent, supported by numerous educational and research institutions including the Indian Institute of Science, Bangalore Institute of Technology, and the International Institute of Information Technology.
