Ref No: AM17796
County Waterford, Republic of Ireland
Quality Manager - County Waterford.
Core objectives of this role:
Driving a compliant work environment, leading a high performing team to deliver against defined business goals, objectives and key performance indicators.
Establishes and maintains the Site's Quality Management System in line with the relevant Standards and Regulations e.g. ISO 9001 and ISO 15378.
Ensure compliance to the Corporate quality management systems, policies, procedures and protocols.
Establish an internal audit program to understand the gaps in the Quality System, drive improvements and achieve the site's quality KPI's.
Supports other site functions in servicing the customer's specification.
Enhance customer relationships by improving quality performance across key indicators.
Drive and embed a preventive action culture via root cause investigation, risk assessments in collaboration with Operations.
Provide leadership for the site in regards to customer and / or product requirements.
Key Responsibilities and Activities:
Provide input into the development and preparation of the QA-part of the European Business Plan.
Input to the development and preparation of the investment budget of European QA.
Establishes the duties and responsibilities of subordinate staff and prepares concise job descriptions.
Regularly assesses the performance of subordinate personnel. Gives counselling and training as appropriate to ensure that existing employees are worthy of promotion when opportunities arise. Act as a coach and mentor to reporting staff and colleagues.
Takes all appropriate actions to achieve results according to the agreed KPI's and agreed personal goals.
Hosting of third party audits, ensuring general audit readiness throughout the business.
Responsible for the quality data trending e.g. CAPA, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site.
Lead and management of risk assessments across the business to drive quality improvements.
Identify and drive quality improvement projects to reduce the number of CAPA's arising within the business
Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
Responsibility for data gathering and reporting of Annual Product Reviews, as required.
Supporting data gathering for regulatory submission, as required.
GMP Training preparation and execution as required including GMP Induction Program, Annual GMP Training (site and supplier) and training in QMS processes as required.
Prepares monthly QA statistics and reports to Senior Director Quality Ops, including the coordination of necessary activities to drive improvements or address adverse trends
Final Batch release decision, including responsibility for the execution and final disposition of IPC and incoming testing as well as trending of this data.
Approves specifications with customers, considering insurance aspects. For multinational and important European customers, agreement with global Quality Systems is necessary.
Ensure sufficient quality support and competencies are in place to support /network projects to ensure flawless transition into Operations e.g. tech transfer
Manage a system for sufficient document and retain sample storage, archiving, retrieval and destruction
Responsibility to accept or reject suspect raw material and auxiliary material.
Audits suppliers and supports issues of delivery specifications for raw materials and auxiliary materials in co-operation with Quality Systems.
Responsibility for the approval of qualification of new equipment and/or validation of new processes.
Defines audit plans for QA process and internal audits for the plant, ensure schedule compliance and sufficiently trained auditors are available to perform audit.
Interface with other sites with respect to sharing of best practices and harmonisation / standardisation of procedures and practices.
Host the site Quality Management Review in line with agreed frequency, ensure action follow-up and timely close out.
Implementation and maintenance of the site's quality management system in adherence to the relevant standards e.g. ISO 9001 and ISO 15378 requirements.
Interested applicants should have:
Ideally a Degree or Master's qualification, with a scientific or technical background.
Six Sigma Qualification an advantage
Good knowledge of GMP and cGMP.
Must be able to develop and maintain a positive customer relationship.
Must be able to organize and prioritise tasks, must be detail orientated and self-motivated.
Must have excellent written and verbal communication skills. Must be able to work in a fast paced environment.