Quality Assurance Specialist
The ideal candidate will be responsible for implementing and upholding quality assurance standards, facilitating inspections and audits, and supporting continuous improvement initiatives in a biopharmaceutical manufacturing environment.
* Develop and maintain quality assurance procedures, policies, and systems to ensure compliance with cGMP regulations.
* Conduct routine self-inspections and monitoring assessments to guarantee adherence to regulatory requirements.
* Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
* Investigate and address deviations, non-conformities, and CAPA to maintain high-quality standards.
* Participate in IT and process automation organizations to provide consistency across all computer systems areas.
* Ensure compliance with periodic review, change control, deviation, backup, and archive processes for systems.
Key Responsibilities:
* Bachelor's degree in Science, Engineering, Quality, or related discipline.
* Minimum 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
* Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
* Excellent problem-solving and analytical skills.
* Detail-oriented with a strong commitment to maintaining high-quality standards.
* Effective communication and teamwork skills.
Benefits:
* A competitive salary package.
* An opportunity to work with a global life-science-recruitment team.
* A chance to develop your skills and expertise in quality assurance.
How to Apply:
Please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you.