Associate Manager-Manufacturing Compliance

18 hours ago

Visakhapatnam, India Pfizer Full time

Use Your Power for Purpose

Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.

What You Will Achieve

In this role, you will:

  • Evaluate corrective and preventive action responses to audit findings for adequacy and timeliness.
  • Ensure Quality Assurance Auditing policies and procedures are current and comply with Pfizer Quality standards and Regulatory requirements.
  • Prepare for and participate in Manufacturing and Supplier Quality Assessment Audits (MSQA) and BOHs Inspections, ensuring successful outcomes and timely implementation/closure of action plans.
  • Identify and manage routine Customer Quality complaints for commercial Drug Products in the global complaints management system (PCOM) and collaborate with the Contractor Quality organization to ensure appropriate and acceptable investigation reports.
  • Assist the Quality Control lab Supervisor with technical issues involving injector functionality, component testing, and protocol execution.
  • Gather, interpret, and apply statistical methods to various Production/Quality related processes and communicate findings through reports, memos, files, and presentations.
  • Implement and adhere to Good Manufacturing Practices regulations and company policies.
  • Conduct detailed audit testing in connection with the investigation of allegations of expense report fraud, conflicts of interest, and other violations of Pfizer policies and procedures or laws.
  • Review area documentation and perform trend analysis on data, controls, and standards.

Here Is What You Need (Minimum Requirements)

  • High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
  • Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
  • Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes
  • Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
  • Excellent technical writing, communication, and presentation skills
  • Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
  • Experience in preparing and participating in audits and inspections

Bonus Points If You Have (Preferred Requirements)

  • Background in handling complaints and utilizing electronic lab systems
  • Strong analytical and problem-solving skills
  • Ability to work independently and as part of a team
  • Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
  • Ability to adapt to changing priorities and manage multiple tasks simultaneously
  • Experience in mentoring and training colleagues

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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