Description
Global Pharmaceutical Company is seeking a Senior Quality Systems Specialist.Reporting to the Associate Director, Global Quality Systems, the individual will be working in a team to support the following activities:
- Maintain systems for the management of Quality Agreements, Annual Product Quality Reviews, CMO Deviations, Internal GMP Audits,
record management and supplier selection.
- Support the expansion of ExM Quality Systems as required, looking to continuously improve the current system through OpEx.
- Support the Deviation and Complaint management system through the management of the Investigations Review Board.
- Act as a Subject Matter Expert as applicable for Corporate Quality Directive review and Impact Assessment.
- Be an advocate for Quality Systems by supporting Quality Initiatives such as Quality Week.
- Compile and perform GMP training.
- Track change controls to ensure that they are closed in a timely manner and as per procedure.
- Support the Quality Authoring, and review of Quality Systems related procedures.
- Prepare for area and regional Quality Council meetings, compile minutes and provide relevant information/metrics for presentation at Quality Council.
- Track CAPA evaluation and CAPA closeout for internal audits, policies and directives compliance, and regulatory inspection observation compliance.
- Participate in preparatory activities for site regulatory, customer and corporate inspections.
Requirements:
-Science related degree in Chemistry or Engineering or Biotechnology
-Minimum of 7 years experience in a pharmaceutical Quality related role, preferably within a Quality Systems team.
-Knowledge of the use of OPEX tools and experience in leading or participation in improvement projects would be an advantage.
-The ideal candidate must have excellent interpersonal skills, be a team player, have good communication and presentation skills
and be flexible and motivated.
An attractive salary and benefits package is on offer if you would like to here more about the company and role please contact me Anna Mooney or apply below with an up to date CV