Quality Assurance Administrator

Company Overview

Pinewood Healthcare is a prominent manufacturer and developer of healthcare products, employing over 300 staff at two sites located in Tipperary and Dublin. Established in 1976 focusing initially on renal care products for the Irish market, the company expanded under Irish ownership until becoming part of the Wockhardt Group in 2006. Wockhardt is a global pharmaceutical and biotechnology company based in Mumbai, India, with more than 7,000 employees of diverse nationalities across multiple countries including the USA, UK, Ireland, Switzerland, France, Mexico, and Russia. The group operates manufacturing and research units internationally, including Pinewood Healthcare’s facility in Ireland.

Role Summary

The Quality Assurance Administrator plays a critical role within the QA & Compliance department at Pinewood Healthcare, focusing on the management and control of documentation to ensure compliance with current Good Manufacturing Practices (cGMP). The role demands high attention to detail and involves supporting manufacturing and quality teams by monitoring adherence to the Quality Management System.

Key Responsibilities

• Manage, distribute, and scan all quality department documents effectively.
• Coordinate training activities, maintain the training matrix, SOPs, and training records.
• Update and amend Standard Operating Procedures (SOPs) and oversee their approval process.
• Support the maintenance and update of the Approved Supplier List.
• Handle applications related to Controlled Drugs Licenses and registrations.
• Communicate updates to global policies and procedures.
• Maintain the Methadone Pharmacy List.
• Support the quality department’s development and maintenance activities.
• Respond to customer queries pertaining to quality.
• Maintain and track quality trends and performance metrics.
• Control and issue official documents such as SOPs, logbooks, and training records.
• Prepare reports using Microsoft Office tools.
• Generate new codes and manage change implementation within SAP.
• Coordinate complaint sample return shipments via courier services.
• Produce packaging specifications ahead of production runs.
• Generate and maintain quality schedules.
• Administer medical device documentation and prepare Product Specification Files.
• Monitor and maintain records related to temperature control devices.
• Schedule and supervise pest control visits, liaising with external contractors on-site.
• Raise purchase orders and manage invoice parking for the quality department.
• Complete quality-related questionnaires for external bodies.
• Perform additional tasks assigned by the department manager.

Key Requirements

• Proficient computer skills, especially with Excel; SAP experience is advantageous.
• Ability to work both independently and collaboratively within a team environment.
• Strong communication skills and meticulous attention to detail.
• Excellent organizational and time management abilities.
• Commitment to complying with company policies, procedures, and ethical standards.
• Effective communication skills, ensuring precise information flow within the quality team.
• Exceptional ability to engage and collaborate with both internal teams and external stakeholders.
• Comfortable working in a dynamic, fast-paced, and regulated manufacturing setting.