About the role
AI summarisedJoin our team where your commitment to quality ensures the delivery of safe and effective products. In this role, you will perform critical analytical testing, method development, and quality control activities while upholding stringent GMP/GLP standards.
BiopharmaOnsite
Key Responsibilities
- Perform Analytical Method Transfer, Validation, and Verification according to SOPs, adhering to ALCOA principles and Data Integrity requirements.
- Conduct analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Write, review, and approve Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
- Conduct Laboratory investigations and propose Corrective and Preventive Actions (CAPA) for identified root causes.
- Review and approve test results, ensuring all documentation aligns with GMP/GLP requirements.
- Support regulatory submissions and queries related to post-transfer activities.
- Train colleagues on instrumentation, methods, and new laboratory procedures.
- Manage Quality Technical Service (QTS) actions and raise/complete change controls with GMP impact.
- Contribute to continuous improvement activities within the QC laboratory or cross-functional teams.
Requirements
- Bachelor's degree with relevant experience, OR Associate's degree with 8 years of relevant experience, OR High School Diploma (or equivalent) with 10 years of relevant experience.
- Demonstrated technical skills in method transfer, method validation, and analytical testing.
- Proficiency in reading and understanding compendial methods, SOPs, technical procedures, and governmental regulations.
- Strong knowledge of Good Manufacturing Practices (GMP) and its application standards/policies.
- Proficiency with unique Quality Control instruments for sample management, retention, interpretation, and evaluation.
- Excellent organizational skills with a strong ability to multitask and manage time effectively.