Quality Assurance Specialist
vor 1 Tag
Job Summary
We are seeking a highly motivated and experienced Quality Assurance Specialist to join our Quality Assurance team at WuXi AppTec. In this role, you will be responsible for ensuring the quality and compliance of our products and processes according to cGMP regulations.
Key Responsibilities:
- Review and approve batch records, QA samples, and other documentation to ensure compliance with cGMP regulations.
- Develop and implement quality systems and processes to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure quality and compliance in all aspects of our operations.
- Support quality metrics and reporting to ensure timely and accurate information is available to stakeholders.
- Participate in internal audits and regulatory inspections to ensure compliance with regulatory requirements.
Requirements:
- Bachelor's degree in a science-related field or relevant discipline.
- At least 1-2 years of Quality Control and/or Quality Assurance experience in a pharmaceutical company or related industry.
- Excellent understanding of cGMP regulations and regulatory requirements.
- Strong written and oral communication skills in English.
- Ability to work independently and collaboratively in a team environment.
- Excellent problem-solving skills and attention to detail.
- Knowledge of quality systems and compliance regulations.
Preferred Qualifications:
- Mastery of quality systems and compliance regulations.
- Excellent leadership and team management skills.
- Ability to communicate effectively with stakeholders at all levels.
- Knowledge of quality metrics and reporting.
- Experience with internal audits and regulatory inspections.
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