- Driving a compliant work environment, leading a high performing team to deliver against defined business goals, objectives and key performance indicators.
- Maintains the Sites Quality Management System in line with the relevant Standards and Regulations eg ISO 9001 and ISO 15378.
- Ensure compliance to the Corporate quality management systems, policies, procedures and protocols.
- 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 Operation’s.
- Provide leadership for the site in regards to customer and / or product requirements.
Essential Duties and Responsibilities:
- The job holder is aware of all relevant ESOPs / EWIs as per company policy that pertain to the position covered by this job description.
- 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.
- Host the site Quality Management Review in line with agreed frequency, ensure action follow-up and timely close out.
- Defines audit plans for QA-process and internal audits for the plant, ensure schedule compliance and sufficiently trained auditors are available to perform audit.
- Responsibility for the data gathering and reporting of Annual Product Reviews, as required.
- Supporting data gathering for regulatory submission, as required
- Takes all appropriate actions to achieve results according to the agreed KPI`s and agreed personal goals.
- Identify and drive quality improvement projects to reduce the number of CAPAs arising within the business
- Ensure capability of hosting of third party audits, ensuring general audit readiness throughout the business.
- Responsible for the quality data trending eg CAPA, OOS, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site.
- Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
- Assist the plant to meet customer expectations and support problem solving efforts
- 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.
- Ensure sufficient quality support and competencies are in place to support /network projects to ensure flawless transition into Operations eg tech transfer. In particular, Ensure alignment with sending sites in terms of inspection plants, defect categorization, including, when required defect libraries.
- 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.
- Manage a system for sufficient document and retain sample storage, archiving, retrieval and destruction
- Input to the development and preparation of the budget and ensure close follow up during the year
- Responsibility for the approval of change controls, qualification of new equipment and/or validation of new processes.
- Interface with other West sites with respect to sharing of best practices and harmonisation / standardisation of West Procedures and practices.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all laws, regulations, policies, work procedures, instructions, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance
- Master diploma with scientific background
- Minimum 4 years of experience in Quality role
Preferred Knowledge, Skills and Abilities:
- cGMP, ISO 9001, ISO 15378
- Green belt training
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.
For more information please apply through the link provided for the attention of Jonathan Power
If you are interested in finding out more about the above role and would like to be considered other suitable roles that we may have available for your skill set – please attach your CV via the link provided
Please submit your updated CV in Word Format
If you are living in Ireland and hold a valid work permit we would love to hear from you, if however you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search