Associate Manager - BQ QMS and Compliance

Pfizer; Andhra Pradesh; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Pfizer India is seeking an experienced QA/QC professional to uphold safety and quality in our microbiology and stability labs. You will own test method transfers, validation protocols, and equipment qualification records while ensuring adherence to CGMP and regulatory expectations.

You will lead investigations, manage CAPA metrics, and coordinate cross-functional audits. Strong microbiology knowledge, risk management, and effective communication are essential to succeed in this on-site role at

Qualifications

• 8+ years of industrial experience in microbiology or QA/QC.
• Strong skills in change and risk management and investigations.
• Experience in microbiological testing and technical review.
• Understanding of pharmaceutical manufacturing, packaging, and QA operations.
• Detail-oriented with robust knowledge of quality systems.
• Good written and spoken communication and interpersonal skills.

Responsibilities

• Create, review, and approve test method transfer and validation protocols and equipment qualification records.
• Maintain compliance with current good manufacturing practices in QC laboratories.
• Support investigations and critical assessments.
• Serve as change control process owner, track CAPA metrics.
• Manage Laboratory Information Management System builds and review lab data.
• Collaborate on cross-functional teams, participate in audits and train junior colleagues.

Skills

Change management

Risk management

Investigations

Quality systems

Written and verbal communication

Education

M.Sc. Microbiology

Tools

LIMS

Job description

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

What You Will Achieve

In this role, you will:

• Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records.
• Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories.
• Support in investigations and critical assessments.
• Change control process owner, tracking CAPA and BQ Metrics.
• Manage Laboratory Information Management System builds, and review laboratory data.
• Serve on cross-functional teams, conduct safety inspections, participate in audit walkthrough and responses, recommend corrective actions, and train junior colleagues.

Here Is What You Need (Minimum Requirements)

• M.Sc. Microbiology with 8+ years of industrial experience with any years of relevant experience
• Strong technical skills in Change management, Risk management and Investigations.
• Experience in microbiological testing and technical review.
• Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
• Detail-oriented with robust knowledge of quality systems
• Effective written and verbal communication, as well as interpersonal skills

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical experience
• Strong understanding of computer system utilization.
• Experience with Laboratory Information Management Systems (LIMS)
• Proficiency in data analysis and interpretation
• Knowledge of regulatory requirements and guidelines
• Strong problem-solving abilities
• Effective time management and organizational skills
• Ability to mentor and train junior colleagues

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