POSITION SUMMARY
The Validation Specialist 1 is responsible for preparing and performing validation and related duties for all Procera (Nobel Biocare's dental CAD/CAM system) and related processes as defined by the Head of Validation. Performing duties as assigned according to various regulatory requirements for medical devices, including SW, consumables/products and hardware in Procera manufacturing sites, under the guidance and regulation of the USFDA and various global regulatory oversight bodies.
He/she will develop and execute initiatives on a local and global basis within the Procera operations network and within the various Test Centers and production sites. The individual will be familiar with regulatory requirements of medical devices and GMP proceses, including the documentation of such.
JOB RESPONSIBILITIES
Develop, define and implement company wide procedures for validation that ensure oversight/track of and verification that validation activities are in compliance with EU/FDA regulatory requirements
To identify areas of improvement for validation systems/procedures and to design and implement required improvements
Generate and/or perform reviews of validation documentation in accordance with relevant standard operating procedures, including but not limited to:
Assist in establishing validation project plans, set acceptance criteria and define the data requirements necessary to ensure that validation work is compliant
To escalate to the qualified person and other key stakeholders of validation matters which may have an adverse impact on the validation status of facilities, equipment, systems or the manufacturing process
Investigate and report quality issues, escalating to management as required
To compile key quality data for the validation program and to make such data available to management to drive a culture of continuous improvement that is fully compliant with current EU/FDA regulations and quality requirements and business needs
To keep up to date with current guidelines and regulatory requirements in respect of internal and external quality requirements
To provide and/or coordinate training in validation related procedures/concepts as appropriate to meet business needs
To represent company-wide validation strategy during internal/external and third-party audits
Implement and maintain quality standard operating procedures, as required
QUALIFICATIONS AND REQUIREMENTS
As the successful candidate, you will have working knowledge of validation within a GMP manufacturing environment, strong attention to detail, have effective communication skills across all personnel levels and functional areas and a logical approach to problem solving
Software development process knowledge, including revision and new product release
Computerized manufacturing and automated processing using SAP or similar resource management products.
Knowledge of Process Validation with a diverse compliance background in cGMP manufacturing
Proven track record in Technical Transfer activities for new and existing processes.
A willingness and ability to travel, also for extended periods of time both nationally and internationally.
