Job Description

SGS is the world’s leading inspection, verification, testing and certification company and is recognised as the global benchmark for quality and integrity. With over 98,500 employees operating from more than 2,500 locations worldwide, SGS delivers trusted solutions across a wide range of industries, including pharmaceuticals and life sciences.

In Ireland, SGS provides analytical and technical services to the pharmaceutical sector through multiple laboratory locations. In 2021, SGS acquired International Services Laboratory (ISL) in Ringaskiddy, Cork, further strengthening its capabilities in pharmaceutical testing, including method development and transfer, release and stability testing, stability programme management, and scientific insourcing services.

At SGS, our work supports the safety and quality of medicines supplied to patients globally. We are committed to maintaining high technical and regulatory standards while supporting the professional development and wellbeing of our people.

We are looking for a experienced QA Officer to Manage major projects within our ISL Labs. As a member of the central quality team, own and oversee certain ISL Quality Management Systems. Act as Subject

Matter Expert for certain quality systems, providing ownership of effectiveness and compliance and providing guidance and coaching on their implementation. Maintain and improve quality compliance, working independently, but aligning with QA team lead. Support audit readiness and execution.

Quality Management (may include some of below)

• Assist in ensuring an effective Quality Management System is in place to ensure that ISL is in compliance with cGMP Regulations and Quality Manual
• Perform/Participate in Quality Audits, including the self-inspection program and contract laboratories (if applicable). Ensure timely follow up of audit observations. Lead/ Support back room during audits
• Provide input to Site Quality Management System Review
• Trend and meet Key Quality Metrics and report them to stakeholders monthly/quarterly and as required
• Ensure efficient management system for SOPs, approval/rejection of SOPs and other quality documents.
• Provide input to Global SOPs concerning ISL (if required)
• Act as ISL equipment lifecycle manager. Act as ISL point of contact for LRM Vendor. Optimise spend from LRM vendor and other maintenance providers
• Ensure calibrations are performed and completed within tolerance windows
• Liaise with Unit Coordinators/IT to minimise disruption caused by instrument downtime
• Oversee the implementation of the Quality Manual and the ISL Quality Plan
• Oversee Quality Risk Management on Site and provide guidance on its application
• Draft/ review QA agreements with Customers and external 3rd party Service Providers.
• Maintain approved list of service providers
• Site Data Integrity Officer – providing guidance on application of requirements
• Site eCompliance Manager, reviewing and approving CSV documents and maintaining oversight on completion of user access reviews and periodic reviews
• Act as ISL Pharmacopeia Subject Matter Expert
• May lead projects

General Quality Processes & Documentation

• QA Approve Laboratory Deviations and OOS/OOE/OOT investigations (if required)
• Transparent and timely follow up of Investigations, Complaints, Deviations and Quality Events to reduce/minimize recurrence (system related)
• Identify effective Corrective/Preventive Actions (CAPAs), trend and support their effective management
• Review and approve Quality related documents, e.g. Equipment Qualification documents, SOPs, Stability Reports, Method Transfer Protocols/Reports etc.
• Ensure changes are raised where appropriate and review/ approve
• Use best practice and knowledge of internal and external issues to improve service and processes
• Look beyond ISL to define and resolve complex issues - Benchmark and liaise with other SGS labs to enhance performance

General

• Deputise for QA Team Lead and QA Facilitator if required
• Ensure all relevant training is maintained & up to date
• Maintain a safe working environment, high housekeeping & 5S standards
• At all times, adopt safe behaviours by exercising due regard for the health and safety of yourself, colleagues,
• and clients, in line with the Company’s policies and procedures
• Maintain the SGS values and behaviours
• Ensure full compliance with the Company’s Code of Integrity & Professional Conduct and always adopt
• behaviour in accordance with SGS Equality & Diversity policy

Qualifications

• Science Graduate in Chemistry, Pharmacy or equivalent education
• Deep knowledge of cGMP and analytical technologies
• Min. of 3 years’ experience in analytical testing

Additional Information

Core Competencies

• Fosters Innovation
• Translates Strategy into Actions
• Develop Self & Others
• Collaborates Effectively
• Embraces Change
• Leads in Uncertainty
• Delivers Superior Results
• Influences Internally & Externally

Performance Indicators

• Revenue, Profit, Margin
• Overdue Compliance Activity, including on time maintenance
• Relevant Audit Observations
• System performance in management system review
• Maintenance Spend
• Customer KPIs, including on time testing, Turnaround Time, project/ Lifecycle milestone adherence.
• On Time Training