UK - Quality Assurance Specialist - CELGJP00009070


Premium Job From Experis IT

Recruiter

Experis IT

Listed on

4th February 2020

Location

Uxbridge

Salary/Rate

£30 - £34

Type

Contract

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

QUALITY ASSURANCE SPECIALIST - UXBRIDGE - £30/£34 PER HOUR - 12 Months QUALITY ASSURANCE SPECIALIST - UXBRIDGE - £30/£34 PER HOUR - 12 Months The work location is UXBRIDGE and is a 12-month contract. Pay rate is between £30 - £34 per hour. The role is working for a global biopharmaceutical company which employs more than 7,000 people located in more than 60 countries. CompetencesThe Contract Senior Quality Assurance Specialist will report functionally to the Director, QA.They will report administratively to the Senior Manager, QA.The primary role of the Contract Senior Quality Assurance Specialist is to support and execute routine quality assurance tasks to ensure compliance with all GMP, regulatory and corporate requirements.Products may be for investigational or commercial use. Duties and ResponsibilitiesResponsibilities may include, but are not limited to, the following:Manage contractor quality compliance activities to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements.This includes:Building and maintaining good working relationships with the contractorLeading 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 contractorOverseeing 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 requestsPerforming QA evaluation and endorsement/approvalReview of associated contractor change control requestsMonitoring progress of related action itemsProcess product complaints. This includes, as necessary:Recording complaint detailsContacting complainant for additional information and/or to request samplesContacting CSP to coordinate manufacturing investigationFinalising complaint investigationPerforming and monitoring trend analyses and reporting to upper managementReview, edit, negotiate improvements to, and approve CSP documentation, including:Process validation protocols and reportsTransfer validation protocol and reportsInvestigations, Deviations, OOS recordsAuthor Product Quality Review reports, as necessary. Or, review, edit, negotiate improvements to contractor supplied Product Quality Review reports.Draft or review, negotiate with contractors, and recommend approval for Quality AgreementsParticipate in self-inspections as appropriateParticipate in external audits of contractor manufacturers and distributors as assignedEnsure logs, databases and files related to the product quality activities are maintainedPerformance of trend reviews and compilation of metricsFor non-product related duties:Develop and/or maintain pharmaceutical quality systems, as assignedAuthor and/or revise standard operating procedures and associated work instructions, as assignedReview and provide recommendations on policies and standards, as assignedSupport GMP/GDP site inspections, as assignedMaintain compliance with personal training requirements Skills/Knowledge RequiredBSc (or equivalent) in a technical or scientific disciplineDemonstrated pharmaceutical quality experience (equivalent to a minimum of 5 years' experience), including experience/knowledge of audit, batch record review, change control, complaint handling, investigations and SOP creation and updateMust 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 complianceMust have strong task management skills with the ability to prioritize, schedule, and control multiple projects and resources simultaneously under tight deadlinesMust have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approachMust have exemplary problem solving and organizational skillsMust have computer proficiencyMust have attention to detail

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