Quality Operations Lead - Microbiology

Job Title: Quality Operations Lead - Microbiology
Contract Type: Permanent
Location: County Waterford
Science and Engineering
Salary: Competitive
Start Date: 2021-11-19
REF: QOM.18.11.21.JP
Contact Name: Jasdeep Panesar
Contact Email:
Job Published: 17 days ago

Job Description

Quality Operations Lead - Microbiology

My client is a leading provider of a wide range of analytical microbiology testing services to a range to clients that operate in the Pharmaceutical Sector. Due to organic growth, they are looking for a Quality Operations Lead with a Microbiology background to join the team.

The purpose of this job is to manage the Quality aspects of the Pharmaceutical Microbiology, Department. The Quality Operations Leader must ensure appropriate systems and controls are implemented to facilitate both customer and quality requirements.

The Role:

• Manage the co-ordination and investigation of non-conformance as part of the non- conformity and CAPA system, including implementations of corrective and preventive actions
• Support the investigation of root cause(s) of non conformances and assist with the implementation of corrective/preventative actions to reduce these events.
• To effectively manage and report all Quality Metrics within the Microbiology team including Exceptions, CAPA’s, Change controls, SOP’s. Ensuring all actions are assigned and tracked to ensure compliance with company metrics
• Completion of Microbiology approval of Quality documentation e.g., Exceptions, CAPA’s, SOP’s, Quality and technical agreements.
• To handle all customer related query and lead the investigation of any complaint, liaising with their team to problem solve these queries if needed.
• To lead internal and External/regulatory audits for area of responsibility, including audit preparation, area tour, support queries during the audit and follow up of actions to closure.

The Candidate:

• Educated to degree level in a Scientific discipline supported by a minimum of 3 years’ experience in a similar role within the pharmaceutical or allied industry.
• Needs to be methodical and organised and show attention to detail.
• Experience of working in a lab based regulated environment with exposure to quality systems
• General awareness of industry quality systems/standards such as ISO9001, ISO17005, GMP, GLP.