The Company Biomap Ltd is a company that provides temperature validation and monitoring solutions to the Pharmaceutical & Biotech Industries. We operate in a heavily regulated environment working with a wide range of companies from Labs, Hospitals, Wholesalers and Pharmaceutical manufacturers.2.The RoleThis role is responsible for understanding the customer validation and meeting their project requirements . Accountable for the management and delivery of all aspects of customer validation projects. Supporting the development of the Validation offering whilst working within the quality management system.3.General Role Responsibilities: Serve as a project manager for temperature mapping and validation projects. Provide technical consultation to customers in order to secure sales orders for mapping and qualification works. Create detailed mapping reports, multigraph &data summary reports using the Global Operations Mapping software. Collaborate with customer project stakeholders, QA and validation managers to develop validation documents ensuring their regulatory requirements and quality standards are met. Translate customer user requirement specifications into executable validation protocols. Create, review, and execute qualification protocols (DQ,IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances/deviations. Assist customers with their investigations and provide information relating to corrective and preventative actions (CAPAs) for any deviations found during mapping and validation works. Provide internal support with regards to the sale of mapping and validation services. Provide advice to customers regarding temperature mapping and equipment qualification. Assist with periodic document review to ensure that validation protocol templates are current and meet the latest regulatory guidelines. Support the requirements of the quality management system by checking and processing calibration certificates and other applicable documents.4.The Ideal applicant must: Reliable, organised and self motivated Excellent customer relationship skills Excellent verbal and written communication skills Ability to function efficiently and independently in a fast paced, changing environments.5.Requirements-Understanding of cGxP validation guidelines and requirements-Experience with equipment qualification in a GMP environments-Experience in working in quality controlled and regulated sites.-Knowledge of FDA, EU Directive Regulations in Biotech, Pharmaceutical and Medical device sectors-Strong focus in achieving customer project deadlines-Ability to organize and prioritise project workload-Excellent Microsoft software skills (Word, Excel, Outlook)Salary:26K-30kPositionType:Full Time
Job Title
JUNIOR VALIDATION TECHNICIAN