Job Description:
We are seeking a highly skilled Senior Quality Assurance Specialist to support our quality systems and drive continuous improvement across the organization.
The ideal candidate will have at least 2 years' experience in Quality Assurance in the pharmaceutical/bio-pharmaceutical industry, with a degree in science, engineering, or business. They will be responsible for collecting and sharing quality system results (KPIs and metrics), reviewing and following up on problems and improvements (CAPAs, Deviations, OOS), and supporting client quality audits.
Key Responsibilities:
* Support Quality Systems: Provide expertise and guidance on quality systems, procedures, and processes to ensure compliance with regulatory requirements.
* Collect and Share Results: Collect and analyze quality system data (KPIs and metrics) and share results with stakeholders to inform decision-making.
* Review and Follow Up: Review and follow up on CAPAs, Deviations, and OOS to ensure timely resolution and prevent recurrence.
* SUPPORT AUDITS: Support client quality audits by preparing documentation, conducting reviews, and facilitating discussions.
* Lead Internal Audit Program: Plan, track, and follow up on actions from internal audits to ensure implementation of recommendations.
* Training Programs: Organize and track training programs to ensure staff meet requirements and are equipped to perform their roles effectively.
* Continuous Improvement: Identify opportunities for continuous improvement in quality systems and implement changes to enhance efficiency and effectiveness.
Requirements:
* At least 2 years' experience in Quality Assurance in the pharmaceutical/bio-pharmaceutical industry.
* A degree in science, engineering, or business (preferred).
* Strong attention to detail, with the ability to see the bigger picture.
* Willingness to travel for company business when needed.