Senior Quality Assurance Specialist
1 week ago
Job Description
">The role of Senior Quality Assurance Specialist involves ensuring compliance with quality standards and regulatory requirements in the manufacturing, packaging, and labeling of intermediates and active pharmaceutical ingredients (APIs).
Main Responsibilities:
- Documentation & Record Management : Reviewing and approving batch records, cleaning records, QC lab worksheets, and GMP documentation to ensure adherence to quality standards and regulatory guidelines.
- Quality Control & Oversight : Disposition of intermediates/APIs, monitoring solvent recovery processes, and conducting quality impact assessments for change control.
- Compliance & Inspections : Supporting regulatory inspections, audits, and ensuring continuous inspection readiness by maintaining GMP compliance.
- Cross-Functional Collaboration : Coordinating with teams for product reviews, issue resolution, and process improvement activities.
- Training & Leadership : Mentoring junior team members, leading quality assurance improvements, and standing in for QA supervisors when required.
- Continuous Improvement : Enhancing quality processes, supporting new product introductions, and maintaining validated GMP systems.
Requirements
- Bachelor Degree/Diploma in Science/Chemical Engineering or equivalent
- Able to commence on a short notice
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