We are looking for a Quality Assurance Operations professional to support day-to-day QA activities within a regulated manufacturing environment. This role will work closely with production, engineering, maintenance, and validation teams to ensure operational activities are carried out in compliance with GMP, internal quality standards, and regulatory requirements.
Key Responsibilities
- Support daily QA operations, including batch record review, change control, documentation checks, and coordination of batch release activities.
- Review and approve GMP-related documents such as User Requirement Specifications (URS), change controls, deviations, CAPA, SOPs, and validation-related records.
- Perform QA oversight for engineering and maintenance-related activities, including asset review, maintenance risk assessment, calibration checks, and engineering system checks.
- Ensure maintenance and engineering activities are properly documented and assessed for quality and compliance impact.
- Support change control processes by reviewing proposed changes, assessing GMP impact, and ensuring required actions are completed.
- Work with cross-functional teams to investigate quality issues, deviations, and non conformances.
- Ensure all activities are performed in accordance with GMP, company procedures, and regulatory expectations.
- Participate in internal audits, inspection readiness activities, and continuous improvement initiatives.
Requirements
- Degree in Engineering, Science, Life Sciences, Pharmaceutical Science or related discipline
- Good understanding of GMP environment
- Strong attention to detail and good communication skills
- Prior experience within QA is preferred
