Senior QA Engineer

SE-QA validation Lead-Normal
Contact person
Additional information
Location Uppsala
Remote 10-20%

Validation leader, on validation min 3-5 years within pharma and/or medical devices.
Experience on commissioning, IQ/OQ/PQ, URS, validation plan for equipment and process.
Experience on GMP/ISO 13485:2016 good documentation and validation activivites min 3-5 years.
Direct availability is mandatory.

Leads validation activities.
Responsible for defining validation activities and developing validation plans for projects.
Responsible for ensuring that all validation activities are completed and that they meet regulatory requirements.
Responsible for producing validation reports in projects where also strategy for re[1]validation is included if applicable.
Responsible for carrying out risk assessment in order to determine the scope of validation.
Responsible for checking that the participants in the validation group have relevant training.
Reviewing and approving requirement specifications, qualification protocols, and reports. Ensures that the requirements are testable.
Approves technical documentation according to the validation plan.

A person who has experience in running validation activities 3-4 years experience.

Also technical experience for qualifications of equipment in the Medical devices/pharma industry.