Validation Specialist
2 weeks ago
Well established, global client carrying out a major site upgrade and expansion - now looking for Validation Specialists on both contract and permanent basis.
The roles will be responsible for and carry out the following functions -
Leadership role within the Quality Department responsible for the management and co-ordination of the site cGMP validation activities.
Support validation activity during design, installation & commissioning of new equipment, processes, packaging lines & facilities and utilities.
Ensure the validated status of site facilities, i.e., equipment, processes, CSV and utilities is complete and compliant with internal local and corporate procedures, relevant regulatory requirements and industry guidance.
Authoring, reviewing, executing and maintaining validation documentation including site Validation Master Plan and Site Validation Strategy.
Support Production departments in validation activities for processes and equipment
Preparation and management of validation plans, protocols and reports.
Support and coordinate with corporate validation team.
Supporting external audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors.
Execute validation protocols and drive to completion any CAPA associated with non-conformances raised.
Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed.
Ensure product quality through robust testing and process monitoring including the use of statistical techniques.
Support Cleaning, Utilities and Computer System Validation.
Essential skills /experience and qualifications
Degree in a relevant science or engineering discipline with a minimum 5 years of validation and qualification experience in a cGMP regulated life science industry,Pharmaceutical, API or Bio-tech.
Excellent day / hourly rates for contract roles - with good salaries & benefits available for the permanent roles ( full details available )
Roles easily accessible from Glasgow, Lanarkshire, Renfrewshire and Ayrshire
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