Job Description

Key Responsibilities

• Lead, conduct and document Product Quality Complaint investigations from initiation through closure.

• Perform root cause analysis using structured investigation tools and methodologies.

• Assess product impact and support risk evaluations.

• Develop, implement, and track CAPAs to completion.

• Collaborate with Manufacturing, Suppliers, Quality Control, Engineering, Supply Chain, and other functions to gather information and drive investigation outcomes.

• Ensure investigations are completed in accordance with GMP requirements, company procedures, and established timelines.

• Identify and recommend continuous improvement opportunities within the Quality Management System.

Qualifications & Experience

• Bachelor's degree in scientific discipline such as Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related field.

• Minimum 3 years of investigation experience within a GMP pharmaceutical or biotechnology environment.

• Experience conducting Product Quality Complaint, deviation, OOS, and CAPA investigations.

• Strong understanding of cGMPs, quality systems, and regulatory expectations.

• Proficiency in root cause analysis and risk assessment methodologies.

• Excellent written communication, analytical, and problem-solving skills.

• Ability to manage multiple investigations and work effectively in a cross-functional environment.