Job title: Quality Manager

Industry: Pharmaceutical / Packaging

Job Summary:

  • 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 e.g. 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 Operations.
  • 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 procedures 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 KPIs 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 e.g. 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 e.g. tech transfer. In particular, ensure alignment with sending sites in terms of inspection plants, defect categorisation 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 sister sites with respect to sharing of best practices and harmonisation / standardisation of company 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

Basic Qualifications:

  • 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.

Duration:  Permanent role.

Location:  Waterford

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