Quality Assurance Specialist
This role plays a pivotal part in ensuring product quality throughout its lifecycle. A seasoned Quality Assurance professional will work in a high-impact, compliance-driven environment.
Key Responsibilities:
* Ensure full regulatory compliance in all project- and product-related activities and systems.
* Develop and implement quality policies, procedures, and continuous improvement initiatives.
* Support supplier qualification processes and collaborate closely with stakeholders to ensure quality standards are met.
* Lead and manage all quality aspects of assigned projects and products, ensuring compliance with regulatory and internal standards.
Responsibilities Continued:
* Oversee a broad range of QA-related areas such as:
* Raw materials, supplier management, production processes
* Specifications, change control, deviations, corrective actions
* Batch release, cleaning validation, audits, and customer complaints
* Quality documentation, stability programs, regulatory compliance
Provide quality support for the introduction of new products, including document review and approval. Ensure that all activities comply with health, safety, and environmental standards. Be present on the manufacturing floor to offer real-time support and oversight.
Qualifications & Experience:
* Bachelor's degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering
* 5 years of QA experience in a regulated pharmaceutical environment - mandatory
* Hands-on experience in a GMP operational setting
* Strong knowledge of regulatory requirements and industry standards