Job Title: Quality Assurance Specialist
Description:
The successful candidate will provide oversight for the engineering lifecycle, ensuring compliance with regulatory requirements and site standards.
Key Responsibilities:
* Ensure that all engineering activities are carried out in accordance with established protocols, policies, and procedures.
* Provide technical guidance and support to cross-functional project teams for new equipment introduction, process improvements, and site upgrades.
* Act as quality representative within engineering-led initiatives, ensuring that quality is embedded throughout all phases of project development and implementation.
* Support the commissioning and qualification (C&Q) lifecycle, including document review and approval of protocols, risk assessments, and summary reports.
* Lead or support investigations related to engineering deviations, non-conformances, and CAPAs, ensuring timely closure and root cause identification.
* Participate in training programs to enhance knowledge and skills in areas such as validation principles, engineering best practices, and regulatory requirements.
* Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance.
Requirements:
* Degree in Engineering, Life Sciences, or a related technical discipline.
* 5+ years' experience in a GMP-regulated pharmaceutical, biopharma, or medical device environment.
* Strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP.
* Hands-on experience with C&Q documentation, risk-based validation, and change management processes.
* Familiarity with engineering systems, such as CMMS, BMS, and automated manufacturing equipment.