
QC Laboratory Specialist
2 days ago
Job Description: As a Quality Control Support Expert, you will play a critical role in ensuring the accuracy and reliability of our laboratory testing processes. Your expertise will be instrumental in maintaining high standards of quality, ensuring compliance with regulatory requirements, and driving continuous improvement in our laboratory operations.
Responsibilities:
- Maintain the site validation master plan and procedures related to ALCM and CPV of GXP laboratory equipment
- Support annual method review in the framework of annual product review
- Lead compendial compliance assessment and adherence for the QC laboratory
- Ensure implementation and maintenance of QC digital solution (core model and local)
- Oversee the execution of qualification and maintenance operations related to QC equipment
- Assure all QC equipment are properly qualified and maintained for their intended use
- Investigate and resolve quality control events, issues or discrepancies in a timely manner
- Provide technical leadership and guidance for the successful completion of major laboratory projects
Requirements:
- University Degree in relevant scientific discipline; Diploma holders with relevant working experience can be considered
- Ideally 5 years of experience in quality control within pharmaceutical with knowledge of Good Manufacturing Practices (GMP), regulatory requirements and expertise on lab instruments
Skills:
- Strong interpersonal relationships to establish partnerships necessary for development of quality culture
- Independent, disciplined and assertive decision-making and execution in laboratory activities
- Good communication skills to advocate QC positions with other functions, including during inspections
- Continuous improvement mindset
- Knowledge of regulations and standards of pharmaceutical industry, Global Quality policies and Data Integrity Requirements
- Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement
Benefits:
- Competitive salary and benefits package
- Opportunities for career growth and professional development
- Collaborative and dynamic work environment
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