Robert Lensen Email & Phone Number

as QA Supervisor;Lead a team of QA Inspectors and the Documentation teamResponsible for vendor management including qualification and performance monitoringLead auditor in internal and external auditsHost client audits and implement CAPA'sCompany certified trainerExperience with TrackWiseas Sr. QA Officer;Responsible for department management; maintaining departmental infrastructure and procedures;Managing direct reports, including defining objectives, performing mid-year reviews and end year appraisals; Project leader of quality improving projects; development of QMS, Part Number Specifications System; Responsible for GMP compliance; support operations and development departments, including planning, executing and reporting internal audits;Responsible for the internal and external audit programs;Deviation management and change control management; including assessment, follow-up and trending;Contact person and host for inspectors, (external) auditors and other stakeholders of suppliers, contract laboratories and AMT partners;QA responsible in project teams of pipeline products;Responsible for inspection of incoming goods system;Responsible for supplier qualification program; including planning, executing and reporting of external audits, handling supplier complaints;QA responsible for equipment qualification, owner of the VMP’s;Responsible for training of personnel in; equipment and facilities qualification, quality indicator reporting, GMP refresh, working with the document management system; Responsible for QA review of system-related documents, process and assay qualification and validation documents and prepare batch release for QPas Director Operations of A-SKINTransfer of products from research laboratory to cGMP production.Knowledge of legal and regulatory affairs.Setup production labarotorium (clean room) for start-up.Management of a GMP facilitySpecialties: Building teams, Coaching, Training, GMP compliance, Biotech, Bio Pharma

Listed skills include Gmp, Quality Assurance, Biotechnology, Quality System, and 10 others.