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Senior Quality Assurance Professional
2 weeks ago
Regulatory Compliance Specialist
We are seeking an exceptional Regulatory Compliance Specialist to join our team. As a key member of the organization, you will play a vital role in ensuring the highest standards of quality and compliance across all aspects of our operations.
This is an exciting opportunity for someone who is passionate about regulatory compliance, has a keen eye for detail, and is dedicated to delivering exceptional results. If you have a strong background in quality assurance, excellent communication skills, and a passion for continuous improvement, we want to hear from you
In this role, you will be responsible for reviewing and auditing batch documentation to ensure compliance with SOPs, GMPs, and applicable regulations. You will also review and approve production and analytical documentation accompanying the release of drug substance, drug product, and packaged finished goods to ensure conformance to appropriate SOPs, GMP, and regulatory requirements, including supporting QP certification.
You will actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. This includes utilising your network to help resolve comments and issues that arise during audit and review. Additionally, you will manage product recalls and stock recoveries as appropriate, identify compliance gaps, and make recommendations for continuous improvement.
Other key responsibilities include creating and maintaining assigned SOPs, performing and reviewing complaints and deviation investigations, change controls, and CAPAs. You will also assist in the induction process for new starters and training of other staff, and compile data for reports and presentations, provide data interpretation, draw conclusions.
Requirements:
- Bachelor degree in a Quality, Science or Engineering discipline, potentially a higher degree, and/or significant industrial experience.
- 3 years of relevant post-degree experience in a GMP environment.
