Offer consultancy services for medical devices as well as pharmaceuticals and Biotech, as well as have a wide range of training available from Risk Management to EU MDR/IVDR and GxP courses.I can provide support activities such as:EU MDR & IVDR transitionAuditing servicesRemediating audit findingsDevice development and CE markingQMS requirementsTechnical documentationRisk managementClinical requirementsStandards complianceSupplier… Show more Offer consultancy services for medical devices as well as pharmaceuticals and Biotech, as well as have a wide range of training available from Risk Management to EU MDR/IVDR and GxP courses.I can provide support activities such as:EU MDR & IVDR transitionAuditing servicesRemediating audit findingsDevice development and CE markingQMS requirementsTechnical documentationRisk managementClinical requirementsStandards complianceSupplier managementProduct registrationRecalls and adverse event managementProduct designUpgrades of equipment & systemsActivities involving validation & qualification, including:EquipmentUtility/FacilityComputer System Validation (CSV)Cleaning processesManufacturing processes Show less

MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. With decades of combined experience in the global medical device industry, we are uniquely qualified to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success.

• Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM, Validation Summary Report• GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting• Performing estimations for Validation and Testing activities• Leading and managing testing and validation activities in synchronization with project scope, schedule and objective• Daily/Weekly status reporting. Risk Management… Show more • Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM, Validation Summary Report• GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting• Performing estimations for Validation and Testing activities• Leading and managing testing and validation activities in synchronization with project scope, schedule and objective• Daily/Weekly status reporting. Risk Management & Timely Communication• Ensure that processes needed for the Quality Management System (QMS) are established, implemented and maintained.• Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS.• Ensure that Quality Objectives are set by top management for measuring the performance of the QMS and that these are regularly reviewed.• Ensure that all suppliers used by the organization are selected, evaluated and reevaluated and that records of this assessment are maintained.• Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. Show less

To manage and develop the Quality Assurance function to ensure that all activities are carried out in compliance with current Good Manufacturing Practice and that the companies ISO 9001:2008, BRC and HACCP accreditations are maintained.• To be responsible for the QMS system.• To implement new systems such as Trackwise, LIMs, Compliance Wire, Everyangle, Eflow, PQMS, EDGE.• To operate as a key member of the technical team driving continual quality improvements across the… Show more To manage and develop the Quality Assurance function to ensure that all activities are carried out in compliance with current Good Manufacturing Practice and that the companies ISO 9001:2008, BRC and HACCP accreditations are maintained.• To be responsible for the QMS system.• To implement new systems such as Trackwise, LIMs, Compliance Wire, Everyangle, Eflow, PQMS, EDGE.• To operate as a key member of the technical team driving continual quality improvements across the function.• Manage the customer complaints, deviations, change control and CAPA systems.• To assist the Head of Technical in ensuring the Company meets it's quality targets and objectives.• To ensure all products comply fully with the contract agreed with the Customer and comply with regulatory requirements.• To host external audits by Customers, regulatory and accredited bodies.• To perform audits of suppliers Show less

Assist in implementing and maintaining the quality programs for the QA department including but not limited to, document control, supplier qualification, Technical Agreement implementation and internal/external audit program. * Review and approval of R&D deviations, OOS, CAPAs, audit comments and other related quality records and providing QA input into their generation. * Assist in the development, review and revision of standard operating procedures for R&D and QA. * Assist in the… Show more Assist in implementing and maintaining the quality programs for the QA department including but not limited to, document control, supplier qualification, Technical Agreement implementation and internal/external audit program. * Review and approval of R&D deviations, OOS, CAPAs, audit comments and other related quality records and providing QA input into their generation. * Assist in the development, review and revision of standard operating procedures for R&D and QA. * Assist in the training and implementation of QA procedures for compliance with GxP. * Conduct batch record and documentation reviews for clinical trial materials and approval of material from CMOs. * Audit R&D and QC raw data where appropriate to ensure that the work has been completed to GxP. * Ensure that GxP validation reports are audited and approved in accordance with the agreed project * schedule. * Liaison with Study Directors, and senior management; communicating information and updates as appropriate. * Approve restricted document types on behalf of QA. Show less

• To plan and prioritise the day to day workload of the section to ensure efficient use of resource and timely validations.• To provide technical support for ad-hoc tasks and new projects, both commercial and PDS.• To negotiate with production staff for access to equipment and agree dates for access.• Assist the investigation of problems and provide support to the business in resolving quality issues• To ensure compliance to the section and site’s procedures.• To ensure… Show more • To plan and prioritise the day to day workload of the section to ensure efficient use of resource and timely validations.• To provide technical support for ad-hoc tasks and new projects, both commercial and PDS.• To negotiate with production staff for access to equipment and agree dates for access.• Assist the investigation of problems and provide support to the business in resolving quality issues• To ensure compliance to the section and site’s procedures.• To ensure members of the section are adequately trained and that training is adequately documented.• To ensure that all documentation is completed in a timely manner.• Review validation protocols and SOPs when required.• To observe process simulations, keeping an event log of all activities during the process simulation.• To archive all critical Production documentation and be able to access information on demand.• Identify personal development needs and agree performance and career development plans in conjunction with the Group. Show less