Manager - Quality Assurance (Investigation)

Overview

This role involves leading investigations within the quality assurance department at a biopharmaceutical company. Responsibilities include examining deviations such as Out of Specification (OOS) and Out of Trend (OOT) incidents, resolving market complaints, and overseeing Corrective and Preventive Actions (CAPAs) by accurately identifying root causes and implementing effective resolutions.

Key Responsibilities

• Lead and manage investigations into deviations, OOS/OOT events, market complaints, and CAPA processes to uncover root causes and ensure corrective measures are in place.
• Work collaboratively across departments to design and implement comprehensive investigation plans that align with regulatory standards, including those set by the USFDA.
• Perform analytical testing and interpret data to validate market complaints and recognize quality or safety trends affecting products.
• Create and update all necessary documentation related to investigations, such as incident reports, risk assessments, and CAPA documentation.

Qualifications and Experience

• Possess 10 to 14 years of experience within the biopharmaceutical sector, focusing on analytical quality assurance and managing deviations.
• Demonstrate a solid knowledge of ICH guidelines pertaining to Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).
• Experience handling change control protocols covering equipment upkeep, cleaning validation, and sterilization methodologies.

Additional Information

This position demands adherence to strict regulatory compliance and involves detailed documentation standards vital to quality assurance and product safety assurance.