Associate Manager - BQ QMS and Compliance

Role overview

Associate Manager - BQ QMS and Compliance at Pfizer

In this role, you will:

Responsibilities

• Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records.
• Support in investigations and critical assessments.
• Manage Laboratory Information Management System builds, and review laboratory data.

Employment details

• Work Location Assignment: On Premise
• Location: India - Vizag, India - Andhra Pradesh

Application details

• 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 .

Additional role details

• 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
• Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories.
• Change control process owner, tracking CAPA and BQ Metrics.
• 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
• 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