Quality Specialist Jobs

About The Position

Requirements

• Bachelor's degree in a scientific, engineering, or health-related field.
• At least 5 years of experience working within the pharmaceutical or medical device industry.
• At least 8 years of experience working in quality within the pharmaceutical or medical device industry in deviation management, pharmaceutical operations, quality assurance, or relevant business areas within the pharmaceutical or healthcare industry.
• Strong working knowledge of 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10.
• Excellent communication and interpersonal skills, including the ability to collaborate cross-functionally and communicate complex quality concepts to stakeholders at all levels.
• Strong problem-solving skills and a proven track record in issue resolution.
• Proficiency in electronic quality management systems such as Documentum, Veeva Vault, and TrackWise.
• Strong organizational and time management skills to meet critical business and functional timelines.
• Detail-oriented, with a keen eye for identifying process improvement opportunities.
• Strong relationship-building skills and the ability to work effectively in team environments across all organizational levels.

Responsibilities

• Support scheduling, hosting, and responding to external client audits.
• Support mock inspections and actual regulatory inspections with health authority agencies, including FDA, EMA, ANVISA, and MHRA.
• Track, trend, and analyze data from past audits, inspections, and quality issues to identify systemic risks and drive continuous improvement.
• Report audit and inspection KPIs and keep senior leadership informed.
• Monitor deviations, audit CAPAs, and health authority commitments to ensure responses and actions are completed and submitted on time.
• Ensure appropriate effectiveness checks are defined for assigned audit CAPAs to assess whether root causes have been eliminated and recurrence prevented.
• Use effective communication channels, tools, and resources to promote awareness and participation in maintaining and continuously improving the audits and inspections program.
• Ensure critical documentation is appropriately documented and stored to support client audits and regulatory inspections.