Site Quality Lead, CTD India

Job Description

About the company:Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .Introduction to the Division /Function:Fisher Clinical Services (Clinical Trials Division)With unwavering dedication to serving clinical research and patients around the world, Fisher Clinical Services is powered by people with an exceptional commitment to delivering end-to-end, high quality global clinical supply chain services. Whether you need primary or secondary packaging of your clinical drug, storage, distribution, logistics, cold chain management, or comparator or ancillary sourcing, our global team can meet the needs of every trial regardless of size, phase or therapeutic area.Role Description/Position Summary:The candidate is to ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Logistics approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Ahmedabad Quality System in compliance with Fisher Clinical Services approved procedure and policies, cGMP, cGDP, and regulatory requirements and guidelines. Liaise with clients, internal and external customers on quality related matters. Also to ensure that supplies, facility and processes are maintained to cGMP standards.Responsibilities:

• Manage and lead the quality team to ensure that all quality procedures and cGMP & GDP standards in relation to the clinical supply chain activities are in place
• Ensure compliance with applicable Corporate and Divisional Quality Policies and procedures
• Hold responsibilities for FCS Ahmedabads quality system, cGMP & GDP system, safety management system, and ensures that the systems are managed and maintained effectively in accordance to the relevant standards
• Responsible for management of non-conformances, (deviations, complaints and quality investigations) and related corrective and preventive actions through to resolution
• Identify regulatory and quality training needs, and delivering training
• Leads liaison with regulatory bodies, clients and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to clients, suppliers and internal associates on regulatory and quality matters
• Identification of facilities and equipment requiring validation and qualification, and the review and approvals of validation related protocols and reports
• Leadership role in service and quality improvement initiatives in line with other functional units to improve market competitiveness, including equipment and processes
• Leads recall activities in conjunction with other functional units in compliance with established procedures and clients requirements
• Responsible for monitoring and control of the production environment, facility hygiene, approval and monitoring of suppliers of materials that affect product quality, approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities, designation and monitoring of storage conditions for materials and products, retention of GxP records, and inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
• Ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorization
• Responsible for approval or rejection, as he/she sees fit, starting materials, packaging materials, intermediate, bulk and finished products
• Responsible for QA batch release
• Responsible for authorization of written procedures and other documents, including amendments, and approve specifications, and other Quality Control procedures
• Responsible for management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement
• Ensure that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management
• Responsible for the management of change control activities
• Conduct internal and external GMP audits
• Host client and regulatory audits
• Perform any other activities as may be required to fulfil business needs

Minimum Educational Qualification:

• Minimum 10 years working knowledge in the pharmaceutical/medical/healthcare settings in the field of quality assurance
• M Pharm / B Pharm / M Sc

Skills, Knowledge and Experience Requirement:

• Good organizational skills and the ability to manage multiple tasks
• Meticulous attention to details
• Good written and verbal communication skills (English)
• Computer Literate
• Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
• Ability to work independently
• Ability to lead teams

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Apply Now,

Keyskills :
deliverycold chain managementqualitychange controltraining needslife sciencesquality systemquality controlcoachingsafety management systemcalibrationcold chainsupply chaincompliance