Jeg har over 20 års erfaring innen for kvalitetsarbeid i farmasøytisk i industri og kan bidra med utarbeidelse av dokumentasjon og revisjonsarbeidet iht GMP / ISO standard.

Inspection Agencies. - Performing FAT, final inspection, Punch, MRB reviews,sign off deliverables, IRN - extended inspection reports to clients. Perform the respective activities and services for all quality control and quality inspections for all discipline product types. Providing services when requested to facilitate quality assurance and inspection in QHSE - providing training in all industries to ISO standard in accordance with ISO 9000, ISO 9001, ISO 9004, API, ISO 17025, ISO 3834-2, ISO 19011, ISO 14001, Directive 2014/68/EU . Providing services in production, implementation and maintenance of management systems: Process audits for all types of service sites, suppliers and manufacturers. Environmental management evaluation. Mechanical Completion, Commissioning,Manufacturer verification, including approval and evaluation. Key abilities are to ensure that the client expectations are meet without any schedule impact or delays for the planned operation use. • Involved in the infrastructure and consulting with the respective parties for the complete supply chain -sourcing, supplier quality auditing & approval including evaluation scrutiny before purchasing. • Supporting and contributing to the ongoing and planned phases of manufacturing to meet the schedules. Verification of efficiency for OTD and planned transportation methods. • Logistic coordination with workshop production, including stock availability for multiple products. • Performing follow up activities of manufacturing and productions, as quality & control for manufactured equipment and expediting the orders, which I endorse at manufacturing with the MC. • A solid and determined team member, advising and leading for a multitude of manufacturing experiences. • Involved with HSE management from the initial risk evaluations Hazid & Hazop at design review. HSEQ representative ensuring evidence and records of are documented. • Performed as safety officer for several major EFAT, SIT operations, ensuring all safety pre-cautions are in place before any equipment is energized. The planned active has passive fire protections systems through testing period. • Experienced with maintenance & service planning with Customer Services for systems in operation. • Perform process Audits according ISO 9001 for all industrial practices, suppliers and manufacturers to the principles ISO 19011. Focused and resourceful team member capable of multitasking, being involved with multi-discipline. My ambition is centred around aiding both colleague’s, suppliers and customers in building positive relations.