Quality Investigation Lead

Pfizer

15+ years

Not Disclosed

India

10 April 30, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Quality Investigation Lead
Location: India – Vizag
Job Type: Full Time
Job ID: 4934355

Our Purpose:
At Pfizer, we are dedicated to breakthroughs that change patients' lives. Every day, we innovate to make the world a healthier place, creating meaningful impacts on global health.

ROLE SUMMARY:
The Quality Investigation Lead will champion the site investigations system, ensuring adherence to manufacturing and laboratory investigation requirements. This role is pivotal in enhancing site investigation operations in compliance with global SOPs, contributing to the achievement of quality and supply metrics.

ROLE RESPONSIBILITIES:

Investigation Process Implementation: Establish and drive a robust investigation platform for the site (OBW for Investigation).
Cross-Functional Collaboration: Influence and collaborate with cross-functional teams to ensure investigations meet supply reliability targets.
Agility & Leadership: Lead the site investigation team to achieve key quality and supply metrics.
Global Investigations Compliance: Champion the implementation of global investigation requirements at the site level.
Program Management & Metrics: Monitor and implement action plans to sustain investigation program metrics.
Global Systems Enhancement: Provide input to network sites and contribute to global system enhancements.
Training & Capability Development: Develop training methods to improve the capabilities of investigators and approvers.
Succession Planning: Implement succession plans for the site investigations team.
Continuous Improvement: Lead improvement initiatives and undertake Lean Six Sigma projects for system and process optimization.
Data Analysis & Reporting: Evaluate trends and data, providing management with results and actionable insights.
Compliance Oversight: Ensure adherence to industry standards, including CAPA closure and investigation timelines.

Compliance Responsibilities:

Cross-Functional Feedback: Interface with teams to provide updates on operations and compliance status.
System Development: Develop systems to ensure compliance with GMPs and Pfizer’s quality policies.
Deviations & CAPA: Ensure that deviations and corrective actions are managed and completed within time frames.

Team Management Responsibilities:

Team Leadership: Manage and guide the investigations team to ensure effective systems and high-quality service to internal and external stakeholders.
Continuous Improvement: Facilitate continuous improvement actions and mentor the team in critical thinking processes.

Statutory Obligations:

Adhere to all workplace health, safety, and legal guidelines.
Follow environmental health and safety protocols specific to the role.

ESSENTIAL REQUIREMENTS:

Education: Bachelor’s or Master’s in Sciences or Pharmacy.
Experience: At least 15 years in Quality Assurance/Quality Control or Manufacturing in a sterile manufacturing facility.
Technical Skills:
- Knowledge of regulatory requirements (USFDA, India FDA, MHRA, EMEA).
- Understanding of cGMPs and various quality tools for investigations.
- Ability to make decisions based on investigation outcomes.
- Experience in regulatory audits/inspections.
Standards, Processes & Policies:
- Familiarity with GMPs for sterile product manufacturing and testing.
- Adherence to global Pfizer quality systems and procedures.

DESIRABLE REQUIREMENTS:

Advanced Competencies:
- Ability to meet business objectives and work with stakeholders to deliver service.
- Strong project management and leadership skills.
- Demonstrated problem-solving and negotiation skills.
Additional Skills:
- Lean Six Sigma certification.
- Experience managing deviations through relevant tracking systems.

Work Location: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction.

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Quality Investigation Lead

Job Description

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