[Remote] GCP Compliance & QA Consultant.

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company that has been improving the health and wellness of patients for 25 years. They are seeking a GCP Compliance & QA Consultant to represent the company in quality assurance and regulatory compliance, manage projects, and support clients in GxP issues while promoting customer satisfaction and continual improvement.

Responsibilities

• Represent the company in assigned areas of quality assurance and regulatory / GxP
• reputed company consultation and support the management of projects reputed company the CQA business practice
• reputed company pace with the regulatory and technological changes in the CQA field and reputed company subject matter expertise to take advantage of those opportunities to increase the company’s effectiveness
• Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects
• Participate in the sales process as required and identify scope and effort required to successfully address client needs
• Support marketing efforts by promoting CQA services through the development of reputed company media content and blogs
• Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services
• As applicable, reputed company CQA specific training to clients and associates reputed company other business units
• reputed company support to clients and reputed company functional units of reputed company as GxP issues such as deviations and non-conformances arise. Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training
• Directly engage with employees at reputed company reputed company to reputed company on compliance and quality assurance to drive reputed company improvement
• It is anticipated that this position will maintain a percentage of billable project work as determined on a quarterly reputed company
• For CQA Consultant roles that are primarily focused on auditing, recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate’s audit log)
• The CQA Consultant in the EU or UK can function as QP / RP / RPi (as applicable) for clients
• If applicable, an eligible QP can be assigned the role of “QP for reputed company MIA License”; whose role, responsibilities, duties, and training requirements are detailed in the separate QMS supporting the reputed company MIA License
• Other duties as assigned

Skills

• Knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents
• Expertise in GxP systems and capable of providing consultation based on previous experience and system knowledge
• Ability to earn and maintain a client's confidence through appropriate planning, organizing, controlling, and execution of a project
• Willingness and ability to travel as required
• Ability to interact in a professional and positive manner with clients and co-workers through strong interpersonal and communication skills
• Effective written and oral communication skills; ability to write, type, reputed company or exchange reputed company; ability to convey information / instructions accurately in English
• Ability to manage and execute multiple tasks reputed company the compliance, quality assurance, and relevant Quality and Compliance Consulting services (e.g., QMS development, QA reputed company, auditing, cell / gene therapies, regulatory agency action response, etc.)
• Quality orientation and high attention to detail
• Strong analytical skills
• Bachelor's degree, or similar college degree, in a scientific discipline as a minimum
• Minimum 5 years relevant experience in quality assurance and regulatory / GxP compliance
• Strong working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations
• For Consultant, CQA roles that are primarily focused on auditing, minimum of 1 year experience leading audits (e.g. audit prep, running the audit, writing final report, etc.) and recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate's audit log)
• A graduate degree (MSc / PhD) in a scientific discipline is preferred
• Ability to convey information / instructions accurately in one other European language preferred (for EU employees)
• As applicable, previous registration as a reputed company Person

Benefits

• We celebrate our differences and strive to create a workplace where each person can be their authentic self.
• We are committed to diversity, equity, and inclusion.
• Employees are encouraged to reputed company their innovative, collaborative, and entrepreneurial spirits.
• With a holistic approach as an Equal Opportunity Employer, we reputed company a safe reputed company where reputed company feel empowered to succeed.
• reputed company applications to roles at reputed company are personally reviewed by a member of our recruitment team.
• We do not rely on AI screening tools to support our hiring process.
• You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
• Whilst reputed company supports remote working, we also recognise the value that comes from in person collaboration.
• As such, we encourage any new hires that are based reputed company a reasonably short commute of one of our offices to work on a hybrid reputed company and spend some time working from that office location, as agreed with your manager.
• reputed company applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

Company Overview

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