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Senior Regulatory Compliance Specialist
3 weeks ago
At our organization, we are driven by a relentless pursuit to develop innovative solutions that improve lives and ensure access to essential therapies across the globe.
Our employees play a critical role in the discovery and development of life-changing scientific innovations. As passionate individuals who are eager to make a meaningful contribution, you will have the opportunity to work collaboratively with our team to achieve our bold ambitions.
We believe every employee deserves a great leader. People leaders are the cornerstone to the employee experience, and as a people leader now or in the future, you will be instrumental in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations.
The position is a Quality Assurance Specialist II, a permanent role within our QA Department, under the QA Packaging & Labelling Support Team. The successful candidate will be required to perform QA review and approval of packaging and labelling associated documents, procedures, changes, qualifications, and GMP deviations. This role requires a sound knowledge of quality assurance systems, methods, and procedures.
The key areas of responsibility for this role include:
- Ensuring compliance with applicable cGxP regulatory requirements
- Participating in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents
- Identifying deviations from accepted practices and exercising judgment to evaluate impact and determine appropriate actions
- Reviewing and approving GMP Deviation investigations and CAPAs
- Performing internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP
The ideal candidate will have prior experience in the pharmaceutical industry, preferably within a QA role. They will also possess a strong working knowledge of current Good Manufacturing Practices (cGMPs) and quality systems, as well as proficiency in applying QA principles, concepts, industry practices, and standards.
Our organization is committed to equal employment opportunity and prohibits discrimination based on protected characteristics or prohibited grounds. We value diversity and inclusion in the workplace and strive to create an environment where every employee feels valued, respected, and empowered to contribute their best work.
If you are a motivated and detail-oriented individual who is passionate about quality and eager to make a meaningful contribution, we encourage you to apply for this exciting opportunity.
