Quality Assurance Specialist in Pharmaceutical Operations
vor 2 Wochen
Overview
We are seeking a Quality Assurance Specialist to join our Pharmaceutical Operations team at WuXi AppTec.
The successful candidate will be responsible for ensuring the quality and compliance of our products and processes. This includes reviewing batch records, conducting quality audits, and implementing corrective actions as needed.
In this role, you will work closely with our QA management team to identify and address quality issues, ensure compliance with regulatory requirements, and contribute to process improvements. Your strong analytical and problem-solving skills, combined with your attention to detail, will enable you to effectively identify and resolve quality-related issues.
Responsibilities
- Review and approve batch records and associated QA samples;
- Conduct quality audits and investigations to identify root causes of deviations and non-conformities;
- Implement corrective actions and preventive measures to address quality issues;
- Collaborate with cross-functional teams to ensure quality and compliance throughout the manufacturing process;
- Develop and maintain documentation related to quality systems and procedures;
- Provide training and support to colleagues on quality-related topics;
- Participate in internal and external audits to ensure compliance with regulatory requirements.
Requirements
- Bachelor's degree in a relevant field (e.g., life sciences, chemistry);
- Minimum 1-2 years of experience in quality assurance or a related field;
- Strong understanding of cGMPs and regulatory requirements;
- Excellent analytical and problem-solving skills;
- Ability to work independently and collaboratively in a team environment;
- Strong communication and interpersonal skills;
- Fluency in English (written and spoken).
What We Offer
- A competitive salary range of $70,000 - $90,000 per year;
- A comprehensive benefits package, including health insurance, retirement savings plan, and paid time off;
- Opportunities for professional growth and development;
- A dynamic and collaborative work environment.
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