
Senior Quality Assurance Specialist
2 days ago
We are seeking a Compliance Specialist to join our team. This role will be responsible for ensuring compliance with regulatory requirements, developing and implementing quality management systems, and providing expertise on cGMP and FDA guidelines.
The ideal candidate will have a strong understanding of sterile injectable manufacturing processes, experience in validation methodologies, and excellent analytical and problem-solving skills.
Responsibilities:- Develop and implement quality management systems to ensure compliance with regulatory requirements
- Provide expertise on cGMP and FDA guidelines to internal stakeholders
- Review and approve market complaint investigations and deviation reports
- Conduct remote compliance checks of controlled documents
- Manage vendor quality activities remotely
- Support and participate in internal and external audits
- Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, or related field
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques
- Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP)
- Strong analytical and problem-solving skills
- Effective communication and documentation skills
- Ability to manage cross-functional teams and prioritize tasks
- Proficiency in QMS tools and software
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