QC Analyst

Pfizer; Indonesia; On-site; IDR 111,600,000 - 200,880,000; Full time

Benefits offered by this job

On Premise

Job summary

Pfizer is seeking a QA professional to conduct internal audits of R&D and Quality laboratories, ensuring readiness for regulatory audits and compliance with policies. The role involves maintaining lab areas, calibrating instruments, and supporting product release analyses.

The ideal candidate will have a BA/BS or equivalent with extensive knowledge of laboratory databases and regulatory requirements for pharmaceutical manufacturing, plus strong teamwork and SOP proficiency.

Qualifications

• BA/BS degree with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience.
• Solid understanding of common laboratory databases.
• Familiarity with regulatory compliance requirements for pharmaceutical manufacturing.
• Ability to work effectively both independently and as part of a team.
• Proficiency in using quality system Standard Operating Procedures.

Responsibilities

• Conduct internal audits of R&D and Quality laboratories to ensure readiness for regulatory agencies' audits.
• Ensure compliance with regulatory policies, procedures, and practices, identifying discrepancies in product safety and recommending corrective actions.
• Maintain laboratory area, equipment, and facilities in a clean, orderly, and operational state, ensuring availability and proper storage of reagents and reference standards.
• Perform verification or calibration of instruments and equipment, supporting chemical and physical analyses on samples for annual product review.
• Develop good working practices and guidelines for staff to use quality system Standard Operating Procedures, managing review and approval of Building Management System Alarms.
• Lead the Continuous Improvement (CI) process for Integrated Manufacturing Excellence (IMEx) within the Drug Product unit, identifying and conducting continual improvement projects.

Skills

Lab databases

Regulatory compliance

Teamwork

SOP proficiency

AI tools interest

Education

BA/BS or equivalent

Job description

Use Your Power for Purpose

Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

• Conduct internal audits of R&D and Quality laboratories to ensure readiness for regulatory agencies' audits.
• Ensure compliance with regulatory policies, procedures, and practices, identifying discrepancies in product safety and recommending corrective actions.
• Maintain laboratory area, equipment, and facilities in a clean, orderly, and operational state, ensuring availability and proper storage of reagents and reference standards.
• Perform verification or calibration of instruments and equipment, supporting chemical and physical analyses on samples for annual product review.
• Develop good working practices and guidelines for staff to use quality system Standard Operating Procedures, managing review and approval of Building Management System Alarms.
• Lead the Continuous Improvement (CI) process for Integrated Manufacturing Excellence (IMEx) within the Drug Product unit, identifying and conducting continual improvement projects.

Here Is What You Need (Minimum Requirements)

• BA/BS degree with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience
• Solid understanding of common laboratory databases
• Familiarity with regulatory compliance requirements for pharmaceutical manufacturing
• Ability to work effectively both independently and as part of a team
• Proficiency in using quality system Standard Operating Procedures

Bonus Points If You Have (Preferred Requirements)

• Experience in a pharmaceutical microbiology laboratory
• Strong problem-solving skills
• Ability to manage multiple tasks and projects simultaneously
• 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.

Quality Assurance and Control