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- Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
- Reviews and approves investigations, CAPA's and change controls for external programs
- Support the day to day management of the batch release process.
- Support annual product quality reviews
- Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.
- Communicates proactively with internal and external partners and management.
- Maintains files such that documents are readily available and easily retrievable.
- Assists department with monthly/quarterly Quality System data review metrics and reporting
- Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.
- Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience
- Experience providing QA support and oversight of GMP manufacturing operation
- Experience successfully leading event investigations, Root Cause Analysis and CAPA
- Experience with network-based applications such as Oracle, TrackWise, Veeva
- Knowledge of current industry trends and ability to use the latest technologies
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Operational Area Quality Senior Specialist, 12 month contract - United Kingdom - Vertex Pharmaceuticals
Description
Operational Area Quality Senior Specialist, 12 month contract - Hybrid, 3 days office-based page is loaded
Operational Area Quality Senior Specialist, 12 month contract - Hybrid, 3 days office-based
Apply locations Paddington, United Kingdom time type Full time posted on Posted Yesterday job requisition id REQ-20837Job Description
General Summary:
The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.
This is a Hybrid role - 3 days a week in the office in Paddington.
Key Duties and Responsibilities:
Knowledge, Skills, Education and Experience:
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
About Us Help Us Achieve Our Mission
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune's Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook , Twitter , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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