By building strong relationships within the scientific community, our medical affairs team has become a trusted partner among patient groups, clinicians and health policy decision makers. We pride ourselves on developing and disseminating information to our key stakeholders so that they can provide the best care for our patients. Because we oversee the entire lifecycle for many of our products, we’re on the forefront of developing valuable and scientifically grounded information that will chart exciting paths forward for many of our innovative brands.
Post : Quality Assurance Manager
Job Description
• Regulatory Knowledge regarding cGMP, FDA regulations, ICH guidelines, and other applicable standard like EU GMPs
• Quality Management Systems (QMS)
• Equipment calibration, maintenance, technical know-how of utilities
• Supplier management
• Auditing and Compliance
• Root Cause Analysis (RCA): Understanding and applications of tools such as A3 PPS, 6 M/Cause and effect analysis/ fishbone diagrams, 5 Whys, fault tree analysis, or other RCA methodologies
• Quality Risk Management: Applications of QRM, and its implementation including tools such as FMEA (Failure Mode and Effects Analysis) and risk matrices
• Hands on experience of Electonic systems
• Data Integrity: Ability to detect and handle data integrity issues as per the regulatory expectations
Candidate Profile
Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.
10-15 years of relevant experience Strong knowledge of cGMP regulations, quality management systems, and industry best practices
Knowledge of Regulatory Affairs Proficiency in the quality management system
Proficiency in conducting risk assessments (ICH Q9) and implementing risk mitigation strategies
Ferring Pharmaceuticals welcome immediate joiner & gender diversity
Preferred Skills :
Laboratory compliance
SCADA/DCS operations
Lab information management system
Send Your Resume : gurpreetkaur.saini@ferring.com
DO MENTION SUBJECT LINE AS _Quality Assurance Manager
Last Date : 30th September 2024
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