Validation Specialist

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Validation Specialist

Holmes Chapel

12 months

£COMPETITIVE Client Overview

The Client is a Swedish company, active as a pharmaceutical contract development and manufacturing organization, with production facilities in Sweden, France, Italy, Spain, Portugal, India and the UK as well as development sites in Sweden, Israel and USA.

For over 20 years we have focused on supporting pharmaceutical companies in taking their products from early development through to commercial manufacturing. Throughout the entire product lifecycle, we are there for our clients. Time and time again, we have delivered innovative solutions.

Role Overview

To develop and execute qualification and validation protocols (DQ, URS, RTM, FRA, FAT, SAT, IQ, OQ, PQ, PV, CV, CSV) and generate reports to support the implementation of site projects.

Key Skills Required

Ensures that all assigned qualification and validation activities are delivered in a timely manner to facilitate the delivery of Q&V projects to plan by:Developing validation master plans, protocols and reports for DQ, FATS, SATS, FRA, RTM, IQ, OQ and PQ and to generate related summary reportsExecute installation, operational and performance qualification protocols and related documentation. Ownership of any related Q&V deviations to resolution and closureOwning, initiating and updating as required Q&V related change controls, events, CAPAs and improvement actionsSupport site engineering project managers in developing and reviewing and approving URS documents, specifications, assessments, acceptance criteria and test/inspection requirements and any other related validation proceduresAssist in pre-qualification commissioning activities

Additional Advantageous Requirements: Have a recognised and relevant Scientific, Engineering or Technical Degree e.g. BSc, BEngExperience in the Pharmaceutical industry, ideally working within a qualification and validation role supporting engineering projects or manufacturing and with experience of typical manufacturing and packaging plants and the equipment types found within a pharmaceutical environmentThey should have a sound understanding of change control and qualification processes and the importance of GxP and HSE

Note: Assigned Q&V projects may involve the following activities:Facility/utility qualificationManufacturing equipment qualificationPacking line equipment qualificationComputerised system qualificationProcess validationCleaning validation

Suitable candidates should submit their CV in the first instance