Quality Assurance Specialist Role
We are seeking a Quality Assurance Specialist to oversee the production of batches and ensure compliance with validated processes and regulatory requirements.
1. Main Responsibilities:
* Verify that all batches meet specifications and are manufactured according to cGMPs.
* Provide quality oversight of Contract Manufacturing organizations, including being the initial point of contact for quality-related issues.
* Escalate quality issues to QA management and assist in establishing and revising Quality Agreements with affiliates and customers.
2. Requirements:
* Key Qualifications:
o Proven experience in quality assurance and control within the pharmaceutical or medical device industry.
o Knowledge of cGMPs and other relevant regulatory requirements.
o Strong analytical and problem-solving skills.
* Additional Information:
o The successful candidate will have excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.
We offer a dynamic and challenging work environment with opportunities for growth and development. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application.