QS/RM/QASM78-22 - Certificazione Qualità, Sicurezza - Lazio, Latina

For International company leader in medical device, we are hiring a

Quality Assurance Site Manager

rectly responsible for the management of the quality Team, the main scope of the Quality Manager System is to maintain the quality compliance of our site in Latina.

Duties & Responsibilities

Check, edit and confirm the quality system remains in adherence to the site certified standards, national and international regulations and established policies/ procedures, both divisional and local, timely notify external bodies of any significant changes to the Site QMS as
Write functional procedures (SOPs) and work instructions (DPs) to meet the criteria of the quality system aligning and implementing divisional and corporate documentation where
Ensure with support of team maintenance of the document control system and provide input to change
Perform Quality System related tasks as directed by
Work with the facility to generate appropriate data and information for analysis in the Site Quality Management Review, regularly update the site Leadership team on the site Quality system performance and opportunities for changes or
Respond appropriately and timely to requests for information from other Smiths Medical Quality team members and site peers.
Ensure training in the area of GMP / GDP/ QMS (as applicable) is efficiently delivered in order to embed knowledge awareness and culture of these programs at the site
Ensure that CAPA documents are complete and up to date, make trend reports and ensure accountability by the "owners" of a Liaise with CAPA Excellence team on all aspects of CAPA including the evaluation of local site CAPA to be elevated to global CAPA. Manage the local CAPA Review Board Process in accordance with Global Procedure
Manage the planning of External body inspections such as Notified Body Organizations, to include coordinating mufti-site resources to ensure assessments are adequately
Manage any subsequent post-inspection response activity - including correction / corrective and verification effectiveness planning, objective evidence compilation and liaison with Regulatory Affairs and Notified Body. Generate and communicate statistics and reports within the Organization, generate lessons learned / near miss items and share with the Global Compliance team for proactive action across all sites.
Work closely with the Global Process Stewards on any need for process
Requirements

 

·        Bachelor's degree In Science with 5-8 years of experience or 9-12 years of experience in a regulated environment without a degree

·        Knowledge of and experience with (use of) ISO 13485, ISO 9001, 2017/2185 (EU MDR), 21 CFR 820, GMP and GDP

·        Spoken and written knowledge of English is essential. Fluent in Italian.

·        Advantage to have experience as an internal auditor or Lead

·        Knowledge of CAPA systems and the implementation of Knowledge of Microsoft Office.

·        Skill in developing training programs that meet individual needs.

 

 The position is located in Latina, Italy.