QA Operations Specialist (Hybrid)
We are currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization. This role involves being a key member of the quality team, ensuring the site has a strong operational compliance focus aligned with cGMP regulations.
Responsibilities:
* Lead cross-functional teams to address compliance issues and achieve project milestones.
* Participate in investigations and risk assessments related to deviations/complaints and changes.
* Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS, and related documentation.
* Provide QA oversight to qualification/validation, technical transfers, regulatory approvals, and commercial/clinical operations.
* Complete QA operational duties related to product disposition.
* Evaluate new regulatory guidance and industry best practices.
* Assist in the development of training curricula and records.
* Support an environment of continuous improvement.
Requirements:
* Degree qualification in Science/Quality/Technical.
* 8-10 years of experience in Quality Assurance, Quality Control, or Technical Operations.
* Project Manager capability with significant understanding of Operations.
* Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
* Experience in quality management systems such as Veeva, SAP, PAS-X.
This is an excellent position for anyone looking to join a leading multinational with a strong focus on compliance and quality assurance.
The ideal candidate will have a proven track record of ensuring compliance with cGMP regulations and implementing quality improvements.