Celgene QA Specialist in Hillingdon, United Kingdom
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The primary role of the Quality Assurance Specialist is to perform routine quality assurance tasks and activities ensuring compliance with all regulatory and corporate requirements.
In addition, this position will assist in the development, organization, and execution of the Pharmaceutical Quality System of Celgene Europe within the Global Quality Organization which will ensure product quality and compliance with all regulatory and corporate requirements for Celgene Products within Europe and Rest of World Markets as applicable.
Products may be for investigational or commercial use.
Role and Responsibilities
For the assigned products (drug product or drug substance) and area of Celgene Global Quality Operations and International Quality Operations you will –
Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements.
Building and maintaining good working relationships with the contractor
Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, OOS records, processes, methods, procedures, documentation, etc.
Recommending quality related improvements to the contractor
Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
Manage change control requests. This includes, as necessary:
Initiating and approval routing of change control requests
Performing QA evaluation and endorsement/approval
Review of associated contractor change control requests
Monitoring progress of related action items
Escalation of change controls to Global Change Control as required
Process product complaints. This includes, as necessary:
Recording complaint details
Contacting complainant for additional information and/or to request samples
Initiating manufacturing investigation
Communicating conclusion to complainant
Performing and monitoring trend analyses and reporting to upper management
Review, edit, negotiate improvements to, and approve contractor documentation, including:
Process validation protocols and reports
Transfer validation protocol and reports
Investigations, Deviations, OOS records
Author Product Quality Review reports, as necessary. Or, review, edit, negotiate improvements to contractor supplied Product Quality Review reports.
Develop and maintain Reference Master Files
Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
Participate in self inspections as appropriate
Participate in external audits of contractor manufacturers and distributors as assigned
Ensure logs, databases and files related to the product quality activities are maintained
Performance of trend reviews and compilation of metrics
For non-product related duties:
Develop and/or maintain pharmaceutical quality systems, as assigned
Author and/or revise standard operating procedures and associated work instructions, as assigned
Review and provide recommendations on policies and standards, as assigned
Support GMP/GDP site inspections, as assigned
Maintain compliance with personal training requirements
BSc (or equivalent) in a technical or scientific discipline
Demonstrated pharmaceutical quality experience - including audit, batch record review, change control, complaint handling and investigations experience
Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly)
Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance
Must have strong task management skills with the ability to prioritize, schedule, and control multiple projects and resources simultaneously under tight deadlines
Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team oriented approach
Must have exemplary problem solving and organizational skills
Must have computer proficiency
Attention to detail
Location: Hillingdon, England, UK
Job ID: 17001535