Quality Assurance Specialist
Responsibilities
- Develop, implement, and maintain Quality Management Systems (QMS) in compliance with GxP, GMP, GLP, FDA, HSA, and relevant quality standards.
- Author, review, and manage quality documentation including SOPs, work instructions, protocols, reports, and quality manuals.
- Oversee key quality processes such as document control, deviations, CAPA, change control, and training management.
- Coordinate supplier qualification activities, contractor oversight, and quality-related risk assessments.
- Support qualification and validation of laboratory equipment, facilities, utilities, and systems, including IQ, OQ, and PQ activities.
- Manage quality records, archival systems, and master schedules while ensuring compliance with data integrity requirements.
- Lead or support internal, external, regulatory audits and inspections, driving inspection readiness and CAPA implementation.
- Assist in the establishment and maintenance of quality systems for GMP cleanroom operations, including environmental monitoring and contamination control initiatives.
Requirements
- Postgraduate qualification in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
- Minimum 4 years of quality assurance experience within a GMP-regulated, accredited, or GxP-compliant environment.
- Strong understanding of GMP, GLP, GxP, FDA, and HSA regulatory requirements.
- Hands-on experience managing document control, deviations, CAPA, change control, and quality system processes.
- Proven experience supporting audits, regulatory inspections, and remediation activities.
- Demonstrated involvement in qualification and validation projects, including protocol and report authoring.
- Working knowledge of ISO 9001, ISO 17025, data integrity principles, and validation lifecycle requirements.
Preferred Experience
- Exposure to cleanroom operations, environmental monitoring, and contamination control programs.
- Experience supporting GMP manufacturing facilities and product production environments.
- Familiarity with EU GMP Annex 15, ICH Q7, Annex 11, and GAMP 5 requirements.
- Knowledge of computerized system validation and data integrity compliance.
FAQs
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