QA Officer (a.i.)

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

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

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