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Pharmaceutical Quality Assurance Manager
hace 1 semana
At FITS, LLC, we are dedicated to providing our clients with top-notch quality talent in the Pharmaceutical, Medical Device, and Manufacturing industries. Our team of experts offers a range of specialized technical services across the Island and in the US, focusing on flexibility, family orientation, and resource well-being.
Job Description:
As a Regulatory Compliance Specialist at FITS, LLC, you will play a critical role in ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements. Your responsibilities will include acknowledging and/or approving investigations for customer complaints, external complaints, and regulatory CAPA, as well as supporting readiness of the facility for regulatory inspections. You will also assist the Associate Director Compliance and auditing during regulatory agencies inspections and conduct internal/external audits following annual site plan.
Key Skills and Qualifications:
- Bachelor's Degree in Chemical Engineering, Biology, or Microbiology Science;
- Five years of experience in pharmaceutical manufacturing industry;
- Experience in GMP, FDA, EU regulations, technical writing, investigation reports, and regulatory/internal audits;
- Strong analytical and problem-solving skills;
- Excellent communication and interpersonal skills;
- Ability to work effectively in a team environment;
- Commitment to serving customers with high-quality research and products;
Benefits:
- Competitive salary and benefits package;
- Opportunity to work with a dynamic and growing company;
- Collaborative and supportive team environment;
- Professional development opportunities;
- Flexible working hours and remote work options;
- Recognition and rewards for outstanding performance;
