Job Description

• Ensuring quality test results of analytical and bioanalytical test methods
• Conducting Internal Audits in the GLP laboratory and CMC departments
• Supplier qualification including Supplier’s audit
• Writing and updating standard operating procedures
• Approve controlled documents as protocol, reports and CoA
•  Review Calibration records, equipment files
• Support Validation of Laboratory test methods, equipment and computerized system
• Provide training to CMC and Preclinical team members
• Deviation ,CAPA and change control management

Requirements

• At least 3 year of experience in pharmaceutical, medical device company – significant advantage
• requirements; i.e., Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and OECD guidelines, Good Documentation Practice (GDP)– required
• BSc/BA in science- required
• MSc/MA in science- advantage
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Ability to prioritize, self-control and diligence in completing big demanding projects
• Strong written and verbal communication skills including good command of English language
• Effective time management and organizational skills
• Permanent attention to details, accuracy in work
• Ability to establish and maintain effective working relationships with coworkers, managers and vendors