Description

Provide Quality Assurance support for manufacturing operations to ensure compliance with GMP standards.

Responsibilities

• Review and approve GMP and cGMP batch documentation against Standard Operating Procedures.
• Manage deviations by raising them to capture potential impacts to product quality and supporting root cause investigations.
• Revise or review QA Operations SOPs to ensure alignment with local, global, and regulatory requirements.
• Identify areas of non-conformance and participate in technical problem-solving.
• Represent QA in project team meetings and collaborate with senior staff on decision-making.

Required Skills

• Minimum 2 years of experience in review and release of GMP batch documentation within pharmaceutical or biotech industries.
• Demonstrated proficiency with TrackWise, SAP, and Excel.
• Direct experience in Supplier Quality and GMP environments.
• Strong understanding of GMP documentation and compliance frameworks.
• Ability to handle multiple tasks concurrently and meet deadlines.
• Effective verbal and written communication skills for technical reporting.
• Proven organizational skills for managing technical resolutions.

Preferred Skills

• College degree in a scientific or technical field.

Key Skills

Education

Any Graduate