Job Description
Our client a pharmaceutical manufacturer now seeks a QA Operational Excellence Lead who will partner with the site Innovation team and Operational Excellence Manager to drive continuous improvement initiatives at the site for the advancement of the quality system and Quality Culture program across - development, clinical and commercial activities at the site.
The successful candidate will operate across the business units and the quality function, direct reports and customers while driving strategic initiatives through people development.
Responsibilities of QA Operational Excellence Lead:
Deviation management; Site overview and trend monitoring.
Lead Continuous Process Evaluation and Process Improvement Program.
Lead the reporting of non-conformance and proposed CAPA are required in addition to highlighting areas of good practice and evidence of conformance to quality requirements.
Inspection Readiness and Management: Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management
Quality metrics & monthly quality system & Senior Management review meetings; (Meeting preparation and coordination of post meeting commitments);
Manage regulatory standard/guidance revision assessments:
Coordinate the site quality plan and ensure plan execution:
Manage compliance initiatives program: PA & Site system & enhancement of site Quality Culture
Vendor Management Program on site
Requirements for QA Operational Excellence Lead:
Bachelor?s Degree in Science.
Proven track record in a quality discipline in the Pharma/Medical Device environment - FDA, EU and regional authorities.
Clear understanding of working within a regulated environment
Excellent communication skills.
Ability to use sound judgment to make effective decisions within appropriate timeframes.
Proven to be self-directed, self-motivated and ability to prioritise competing priorities.
Relationship Building: establishing excellent working relationships with all functions within the business unit and QA team.
Larry on +353 (0) 1 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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