Company 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.
Job Description
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
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