Senior QA Specialist - Compliance and Quality Systems
This is an excellent opportunity to join a leading multinational as a Senior QA Specialist - Compliance and Quality Systems. The role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates.
Key Responsibilities:
* Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes.
* Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
* Support implementation and training for site Quality Systems and ensure activities are in compliance with the current Quality Manual Requirements.
* Support completion of Quality Systems activities e.g. related to Documentation Management, Auditing, Deviation Management, Change Control, Supplier Management and Quality Risk Management, per schedule.
* Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
* Create and maintain assigned SOPs.
* Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements at the start-up facility.
* Support site QA Operations and QA Validation colleagues, as required.
* Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
* Support gathering of site metrics.
* Ensure the escalation of compliance risks to management in a timely manner.
* Additional activities as assigned by the manager/supervisor.
Required Skills and Experience:
* Degree qualification (Science/Quality/Technical).
* 2-3 years' experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
* Previous experience in QMS development and maintenance, QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
* Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar.
The estimated salary for this position is $60,000 - $80,000 per year, depending on location and experience.