Senior Quality Assurance Specialist
hace 3 días
Company Overview: At Chemo, we are dedicated to ensuring the highest standards of quality in our pharmaceutical products. Our team works tirelessly to maintain compliance with regulatory requirements and internal standards.
Salary: $80,000 - $110,000 per annum, depending on experience.
Job Description
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our QA department, you will be responsible for ensuring that our products meet the highest standards of quality and safety.
Responsibilities:
- Raw material supplier homologation and system maintenance
- Audits annual plan preparation and support regarding audit performance
- Register, investigate, and respond to quality complaints from customers
- Prepare PQRs according to timelines included in the annual plan, internal procedures, and TA in force
- Evaluate and follow up on CAPAs and CC systems
- Perform specific tasks assigned
- Provide GMP basic training to new staff and register and follow up on their progress
- Collaborate in external audits from customers and Authorities and conduct shelf-inspections according to the annual plan
Required Skills and Qualifications
To be successful in this role, you will need:
- Education: Degree in Pharmacy or Chemistry or Sciences
- Languages: Intermediate or high level of English required and bilingual in Spanish
- Experience: A minimum of 3 years' experience in a similar position
- SPECIFIC KNOWLEDGE: Knowledge of EU & US GMPs, quality systems (CAPAs, PQRs, audits support, supplier management, change controls, etc.) in pharmaceutical companies. SAP and Trackwise knowledge is valuable
Benefits
We offer a comprehensive benefits package including health insurance, retirement savings plan, and paid time off.
Others
This is an exciting opportunity to join a dynamic team and contribute to the success of Chemo. If you are passionate about quality assurance and compliance, please apply today.
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