Quality control manager
Job Description
Our Client is looking for Quality Control Manager-with Small molecules, validation, analytical chemistry, methods validations etc. experience…..!!!!!
Summary: Manage Small Molecules/Oral Solid Dosage analytical test methods validations and transfers for release and stability testing of commercial pharmaceutical products.
Manage complex scientific knowledge of analytical methods and updates . Manage a staff of qualified scientific employees and provide guidance in the area of expertise.
RESPONSIBILITIES:
• Method design (re-design) and validation (re-validation)
• Method performance monitoring (trending), control and troubleshooting
• Methods transfer working with internal and contract sites
• Author analytical regulatory sections and response to questions
• Work with interconnected departments and other groups in Pharmaceutical Operations
• Analytical expert for assay optimization, validation and transfer
• Present analytical issues and findings to senior management
QUALIFICATIONS AND SKILLS NEEDED:
• A bachelor’s degree in analytical chemistry with 5+ years or a Master’s with 3+ years of leadership and experience in a pharmaceutical/biotechnology industry.
• Experience directing activities related to analytical method development, qualification and validation of Small Molecules, Oral Solid Dosage assays, method performance monitoring, methods transfer and working with external laboratories.
• Experience with regulatory writing of analytical sections and response to questions
• Excellent communicator, author and creative thinker with extensive knowledge in the area of expertise
• Specific techniques include chromatography, particle size, XRPD, Dissolution and Disintegration, ICP-MS, KF and compendia methods
• Excellent project and people manager who can motivate, direct projects, and align scientific
Regards
Pooja Mishra
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
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