Quality Assurance Professional
We are seeking a Quality Assurance Professional to join our team. In this role, you will play a critical part in ensuring the quality of products across various industries.
Key Responsibilities:
* Conduct thorough audits and reviews of batch documentation to verify compliance with SOPs, GMPs, and applicable regulations.
* 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.
* Develop and maintain strong working relationships with functional areas to facilitate collaboration and understanding of roles and responsibilities.
* Cultivate a network to assist in resolving comments and issues that arise during audit and review.
* Manage product recalls and stock recoveries as necessary.
* Identify compliance gaps and recommend strategies for continuous improvement.
* Create and maintain assigned Standard Operating Procedures (SOPs).
* Perform and review complaints and deviation investigations, change controls, and Corrective Action Preventive Actions (CAPA's).
* Support the induction process for new starters and training of other staff.
* Analyze data for reports and presentations, provide data interpretation, and draw conclusions.
* Execute all assignments to meet standards of compliance, efficiency, innovation, accuracy, and safety in accordance with regulatory requirements.
The ideal candidate will possess a degree in a Quality, Science, or Engineering discipline, potentially a higher degree, and/or significant industrial experience. 3+ years of industrial experience in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations are also required. Effective communications (oral/written) and interpersonal skills are essential.