Jobstore are recruiting on behalf of a leading Lancashire based manufacturer for a Technical Author to be responsible for producinghigh-quality validation, compliance, and technical documentation to support the design, manufacture, and regulatory assurance of the companys products.reporting directly to the Compliance Engineer you will;? Prepare the required validation documentation including the Requirements Traceability Matrices,Design Qualifications, Factory Acceptance Tests, Installation and Operation Qualifications, OperatorManuals, Risk Assessment and Method Statements.? Produce Standard Test Protocols and procedure manuals.? Work closely with the Compliance Engineer to scope out and implement continuous improvement inthe production and management of validation documentation.? Liaise directly with other areas of the business such as the Production, Customer Care, Sales, andAfter Market departments on behalf of the Engineering Team.? Work according to the applicable protocols, guidelines and legal standards as required.? Work with our customers to understand their requirements and respond to their requests forcompliance information? Monitor and report on new and updated regulations and standards and their impacts on thecompanys products.
What we are looking for:? Degree qualification or equivalent, or experience in a compliance role in a similar industry.? Knowledge of medical/pharmaceutical validation requirements is desirable? A proven track record in the development and execution of validation protocols such as riskassessments, design qualifications, FAT, IQOQ, and Operator Manuals or similar.? Working knowledge of CE, UKCA compliance and any associated directives; including but not limitedto Low Voltage, EMF, and ATEX.? Experience working under GMP- desirable but not essential? Strong team player with excellent communication skills, both written and verbal.? High attention to detail and commitment to accuracy.? Proactive, analytical, and able to work with minimal supervision.? Comfortable working within regulated environments.
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