Quality Assurance Specialist

Description:

Responsibilities:

• Develop and maintain the Quality Management System (QMS) in compliance with FDA cGMP and other regulatory standards.
• Conduct audits and reviews to ensure strict adherence to quality processes and identify areas for improvement.
• Manage document control processes, including creation, review, and archiving of quality documents such as SOPs, batch records, and validation protocols/reports.
• Thoroughly review batch production records for compliance with established procedures, specifications, and regulatory requirements.
• Address and resolve any discrepancies or deviations identified during review.
• Evaluate proposed changes to processes, systems, or equipment to assess their impact on product quality and compliance.
• Manage the change control process, including documentation, assessment, and implementation of changes.
• Qualify suppliers and conduct thorough supplier audits to ensure adherence to quality standards and regulatory requirements.
• Effectively manage supplier deviations, complaints, and non-conformances to ensure timely resolution.
• Develop and deliver comprehensive training programs on quality systems, procedures, and regulatory requirements.

Qualifications:

• Bachelor's degree in pharmacy, chemistry, biology, or related scientific field.
• Minimum of 3-5 years of experience in pharmaceutical quality assurance, with a strong understanding of FDA cGMP regulations and industry best practices.
• Proven track record of managing quality management systems (QMS) and driving continuous improvement initiatives.
• Experience in batch record review, change control management, and supplier quality management.
• Strong analytical skills with the ability to identify problems, propose solutions, and drive resolution.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and influence stakeholders at all levels.