Associate Manager - BQ QMS and Compliance

Pfizer; India; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Pfizer India is seeking a Senior QA Scientist to create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records, ensuring strict adherence to GMP in our QC and Stability laboratories. You will lead investigations, drive CAPA and BQ metrics, manage LIMS builds and data review, participate in cross-functional audits, and mentor junior colleagues.

The role requires an M.Sc.

Qualifications

• M.Sc. Microbiology with 8+ years of industrial 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 QA operations.
• Detail-oriented with robust knowledge of quality systems.
• Effective written and verbal communication and interpersonal skills.

Responsibilities

• 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 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 walkthroughs and responses, recommend corrective actions, and train junior colleagues.

Skills

Change management

Risk management

Investigations

Microbiological testing

Technical review

Pharma operations

Quality systems

Communication skills

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.**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