Search Options
View Cache (Job ID 13815672)
Employer CPL
Job Title Associate Director Of Quality
Description

Associate Director of Quality.
My client is a Global Pharmaceutical company based in Dublin North and is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world and in conjunction with the CPL Group is looking to recruit for an Associate Director of Third Party Quality. The Associate Director is responsible with Management support for the development and implementation of Quality Management Systems to support ongoing and enhanced oversight of Contract Organizations involved in the manufacture, testing packaging labelling of products within the oversight and batch release portfolio of 3rd Party & Commercial Quality.


Key Responsibilities:
•Providing QA oversight of GMP systems operating at CMO’s and internal/external supply chain operations. Including the coordination and management of Quality System processes such as Deviations, CAPA and Change Control, Complaints, Annual Product Quality Reviews, Quality Management Review ensuring adequate oversight and supporting continuous quality system improvements.
•Provide guidance and support to clients in defining QA needs for new and existing systems based on regulatory agency requirements and business objectives.
•Support the maintenance and development of Global TrackWise workflows used for Change Control, Deviation Management and CAPA.
•Support the generation and routine update of quality agreements with affiliate organizations and MAH to support existing licenses and authorizations.
•Ensure that the appropriate SOPs are in place and in line with Corporate Quality Standards .Ensure cGMP documentation compliance, such as Standard Operating Procedures, investigations, reports and product supply chain maps are current and up to date.
•Participation in preparatory activities for site regulatory, customer and corporate inspections (HPRA, FDA, TUV)
•Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
•Ensures schedules for review and approval of GMP documents and other key system outputs are maintained to meet the needs of Commercial Operations groups for all key projects.
•Provide QA and Compliance support to internal and external stakeholders in relation to quality management systems and processes.
•Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
•Identification and active participation in the resolution of potential problems through Continuous Improvement initiatives prior to their having an adverse effect on the established business
•Develop, track and maintain training records for all TPQC QA personnel & site wide cGMP training records, assessment scores and course evaluation forms for each department.
•Identify Key performance indicators and develop and maintain metrics for trends for reporting and monitoring these indicators where requested.
•Complete and conform to all training requirements for job role, including company-required and job role-specific training.
•Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
•Perform assigned task in accordance with procedural requirements and scheduled timelines. Notify the Associate Director and other impacted stakeholders if procedural requirements or timelines are not being met.

Candidate Profile
•Bachelor’s Degree required. Chemistry or Life Science degree preferred. Some exceptions made for those candidates demonstrating equivalent knowledge and having pharmaceutical experience.
•Minimum of 7+ years’ experience in QA/Compliance in pharmaceuticals or related industry.
•Detailed knowledge of cGMP requirements and industry best /current regulatory expectations.
•Strong analytical skills and knowledge of quality systems.
•Demonstrated written and verbal communication skills.
•Ability to provide project leadership and guide successful completion of quality projects.•Computer literate; proficiency in using Microsoft Office suite; effective and clear verbal and written communication skills.


If you are interested in the role, please submit your CV to aileen.cahill:cpl.ie or call me on 016146007 for a confidential conversation today.

This job originally appeared on RecruitIreland.com
Location Dublin North
Date Added 63 days ago
Apply Link
";