Quality Specialist

6 days ago

Paddington, United Kingdom Vertex Pharmaceuticals Full time

Job Description

GDP Operational Quality Specialist role supports international QA as well as local QA staff in the affiliates. The focus and ability to meet team targets will help in completing critical deliverables. GDP Operational Quality Specialist will also be required to develop and enhance processes to continuously improve and streamline existing quality processes to support these activities. The knowledge and skills this position holder brings will contribute towards the goals and objectives of the team.

Key Responsibilities:

- Management of International Quality inbox (intake, triage and timely responses to QA queries)
- Responsible for coordinating product returns, including liaising with 3PL and RPs responsible, providing regular return processing updates.
- Responsible for managing the intake, triage and entering minor Vertex internal deviations and 3PL distribution complaints and/or deviations into the quality system. Liaise with relevant stakeholders to obtain full information to initiate investigation and root cause analysis as per Vertex procedures. Track completion and closure in a timely manner.
- Support GDP operational quality in gathering relevant documentation for disposition on temperature excursions
- Complete any quality actions assigned (updating quality documents, issuing memos etc)
- Raise risks/issues with timelines and seek support in timely resolution.
- Maintain up to date product flow maps for International Quality.
- Initiate change control records as required.
- Support inspection readiness activities as well as tracking post-inspection CAPA action completion timelines.
- Utilize and boost learnings from audits/inspections to advance inspection readiness.
- Provide regular QMS data reports to relevant GDP stakeholders and lead the GDP QA governance meetings with record owners and approvers for tracking deviations, change controls, CAPAs, Effectiveness checks, TQAs and associated metrics.
- Prepare relevant QMS data reports for QMRs, inspections, governance meetings and presenting relevant KPIs
- File quality records according to Vertex records retention policy and procedures.
- Collaborate with internal and external stakeholders supporting the GDP team to manage other the day-to-day QA Operations

Key Requirements:

- Good knowledge of project management tactics and tools to support meetings, assist with project planning, and facilitate completion of tasks
- Ability to evaluate straightforward quality matters against established procedures, analyzing information and standards to make judgments
- Good knowledge of global GMP/GDP requirements governing oral drug products, the product lifecycle, and manufacturing practices.
- Ability to take accountability for the quality and accuracy of own work and effectively communicate with the customer and ensure mutual understanding
- MS Office
- Knowledge of current Good Distribution Practices or Good Manufacturing Practices and the applicable GxP regulations and standards
- Proven experience working in a QA, GMP or GDP pharmaceutical environment
- Previous experience in Competent authority, Regulatory body inspections and audits.

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.

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