MQA upstream Associate

6 days ago

Visakhapatnam, India Pfizer Full time

Key Responsibilities:

Terminal Sterilization Block Operations (Solution/Emulsion Preparation, Vial/Ampoule Washing, Depyrogenation, Filling, Capping, and Collection)

Ensure compliance with current Good Manufacturing Practices (cGMP) across all sterilization block operations

Maintain regulatory standards and documentation in alignment with cGMP requirements

Adhere to Pfizer manufacturing policies and procedures

Review Electronic Batch Records (eBR) and assess AMPS (Agile Manufacturing Production System) exceptions with supervisor support

Audit batch reports and equipment trails for accuracy and compliance

Conduct alarm impact assessments and approve trend reports

Monitor start-up and in-process activities for adherence to batch records and SOPs

Ensure manufacturing practices align with approved standards and procedures

Perform CCTV monitoring to oversee manufacturing process areas

Conduct daily walkthroughs per cleanroom behavior/coaching protocols and report observations for resolution

Review daily NVPC (Non-Viable Particle Count) workflows and approve trend reports

Escalate any non-compliance issues to the supervisor

Identify process gaps and contribute to simplification initiatives to reduce downtime and improve efficiency

AMPS Responsibilities:

Review and approve Master Recipes

Review and approve Master Workflow

Review and approve Master Data (Graphs, Classes, Entities)

Must-Have Qualifications & Expertise

Education : B. Pharma / M.Sc. in a relevant discipline

Experience : 2–5 years in pharmaceutical manufacturing, specifically in Quality Assurance or Production

Strong knowledge of solution preparation processes

Familiarity with filling and capping equipment

Proven experience in reviewing batch records and NVPC trend reports

Hands-on expertise in manufacturing activities within sterile environments

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

  • Mqa Upstream Associate

    1 week ago

    Visakhapatnam, Andhra Pradesh, India Pfizer Full time

    Key Responsibilities: Terminal Sterilization Block Operations (Solution/Emulsion Preparation, Vial/Ampoule Washing, Depyrogenation, Filling, Capping, and Collection)- Ensure compliance with current Good Manufacturing Practices (cGMP) across all sterilization block operations- Maintain regulatory standards and documentation in alignment with cGMP...

  • MQ Upstream Associate

    6 days ago

    Visakhapatnam, India Pfizer Full time

    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...

  • MQ Upstream Associate

    2 days ago

    Visakhapatnam, India Pfizer Full time

    Job Description 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...

  • Associate

    3 weeks ago

    Visakhapatnam, India Pfizer Full time

    Must-Have Bachelor's Degree In Pharmaceutical or its equivalent 5+ years of experience Prior relevant experience in a regulated manufacturing operations environment Working knowledge of Upstream/Downstream Current Good Manufacturing Practices (cGMP) manufacturing operations Experience on documentation and batch review process. Strong people management...

  • Mq Upstream Associate

    2 weeks ago

    Visakhapatnam, Andhra Pradesh, India Pfizer Full time

    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...

  • Team Leader

    3 weeks ago

    Visakhapatnam, India Pfizer Full time

    Use Your Power for PurposeOur breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts...

  • Team Leader

    6 days ago

    Visakhapatnam, India Pfizer Full time

    Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts...

  • (Urgent) Team Leader

    2 days ago

    Visakhapatnam, India Pfizer Full time

    Job Description Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes....