SGS are the world’s leading testing, inspection and certification company SGS Group. We deliver solutions to a wide range of industry sectors in Ireland. Enjoy a truly rewarding career in a global, multicultural organisation with a proud heritage that has been making the world a better, safer place for over 140 years.

Our client services include providing SGS QC analysts and technical support staff on-site to fulfill staffing requirements (Scientific In-sourcing), all under the supervision and guidance of ISL technical and operational teams. Like all SGS personnel, they are committed to upholding stringent technical and GMP standards, ensuring the safety of medications for the multitude of patients relying on the products we test.

Due to growth, we have an exciting opportunity for an experienced QC Lead Analyst to join our growing Scientific In-sourcing team.

Lead a client-based team of QC analysts to meet client requirements. Plan workload and manage quality, safety and operational performance of team. People management responsibility, including oversight of training and development and establishing empowerment and accountability through effective leadership and coaching. Ensure two-way communication between SGS and client.

Role will also involve acting as an analyst where required. Testing of pharmaceutical substances e.g. raw materials and drug substances in a GMP environment in accordance with clients’ procedures and quality system. Demonstrating own knowledge and expertise in complex testing, complex decision making and leading troubleshooting. Optimisation of methods and equipment. Leads improvements in quality, safety, sustainability and throughput. Operates with little supervision.

Lead Analyst:

• Act as SGS daily point of contact with client, ensuring strong communication with the client and SGS
• Plan workload, interfacing with client planning tools and daily/weekly governance processes
• Oversee execution of the operational plan to ensure optimal productivity and reliable execution
• Lead team to ensure that all testing is completed on time, right first time and to the required specification
• Optimise and report key performance indicators- quality, safety, productivity, on time delivery
• Ensure provision of excellent customer service, identifying and implementing continuous improvements in efficiency and service
• Problem solving and resolution of queries, linking with support resources in SGS and in the client
• Ensure adequate cross training to meet client needs and cover within the team
• Review and verify data generated
• Maintain laboratory facilities and equipment used by the team- ensure high housekeeping standards
• Ensure lab supplies are available as required
• Review and approve GMP documents such as SOPs, temperature monitoring profiles, calibration records
• Be qualified in and administer basic First Aid

Support in preparation and execution of audits

People Management:

• Performance Management - Manage the Team. Provide guidance, set goals, assign tasks and monitor progress for effective team performance. Conduct regular 1:1s and twice-yearly formal reviews. Provide input to ratings and salary/ promotion decisions. Assess performance and provide feedback on strengths and areas of improvement.  Provide support with personal development, coaching and mentoring to support employee growth
• Build a strong team and manage team members in accordance with policies
• Lead communication within own business unit and support cross-SGS communication
• Support the integration of new staff. Ensure that all personnel are properly trained and qualified to execute their duties. Ensure training is completed before deadlines
• Build succession plan for roles within own business area and input to those in other teams. Execute actions to support planning
• Support SGS HR/Payroll team in liaising with direct report
• Manage HR System- Approve leave and timesheets and manage absence within business area
• Coach in maintenance of the SGS values and behaviours

QC Analysis

• Receive training from SGS and client and get qualified in relevant analytical techniques
• Carry out routine testing in accordance to the valid testing procedures and regulatory requirements meeting or exceeding standard testing times
• Execute new/multiple complicated methods/techniques
• Author Method Verification documents and execute
• Author Validation/ Transfer documents and execute
• Experienced in method feasibility and development, providing guidance to others
• Participate in local and global  projects as required
• Responsible for complex decision making and optimisation of techniques
• Routinely provides training, monitors progress and ensures all records are completed in a timely manner
• Demonstrate strong troubleshooting experience to resolve issues with minimal delay. Act as a go-to specialised technical resource
• Notify appropriate contact and document results and investigations for any atypical or aberrant results- lead laboratory investigations and deviations according to cGMP.  Qualified as an investigator on client system
• Complete secondary review of solution preparation and review of instrument daily calibrations. Qualified reviewer across multiple techniques
• Ensure correct data entry to LIMS
• Assess/ trend testing results generated in the laboratory
• Ensure that all target dates are met. Update visibility tools and communicate status of testing at meetings
• Plan inventory and status of materials required for analysis
• Work as part of the team ensuring customer expectations are met and exceeded

Equipment

• Maintain equipment to enable efficient use, management of consumables etc.
• Ensure that laboratory equipment is well maintained and calibrations are carried out at the designated frequencies
• If required, Subject Matter expert on projects. Perform evaluation of specialised equipment. Lead development of SOPs and Performance Qualification for new equipment types 

General QC

• Maintain own work, documentation and area to a high standard, ensuring audit readiness and work completed Right First Time and on time
• Perform duties as instructed with little to no supervision. Work in a self-directed manner
• Be a subject matter expert supporting quality audit execution
• Maintain laboratories to a high housekeeping standard and support 5 S activity
• Lead Identification and implementation of safety, environmental, quality and service improvements
• Create/update necessary documentation (e.g. SOPs, Analyst Guidance Documents, templates)
• Occasionally deputises for other Lead Analyst
• May support cross site improvement or troubleshooting activity with labs in other locations
• May support proposals for introductions of new technologies or services

General 

• 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
• Identify unsafe practices and propose solutions
• Raise Near Misses and Behavioural Based Safety Observations if trained, per the client system
• Maintain the SGS and client’s values and behaviours
• Ensure full compliance with the Company’s and Client’s Code of Integrity & Professional Conduct and always adopt behaviour in accordance with SGS Equality & Diversity policy 

May include

• Lead safety in own area and actively contribute to site safety committee
• Support in other client initiatives
• Carry out role of first-aide
• This is not an exhaustive list of duties.

Performance Indicators

• QC Analyst Productivity
• Team Performance
• Safety KPIs, including Safety Incidents/ Near Miss/ Injuries
• Quality KPIs, including successful audit performance, Lab Error Rate, Overdue Compliance Activity
• Customer KPIs, including on time testing, Turnaround Time, Milestone Adherence, On Time Training

• Bachelor of Science Graduate in Chemistry or equivalent education (NFQ Level 7)
• Demonstrated competency equivalent to more than five years’ experience in analytical testing (HPLC, GC, UV, wet chemistry, dissolution, etc)
• Familiarity with current Good Manufacturing Practices and sound knowledge of analytical technologies
• Proven track record in demonstrating leadership and influence

Core Competencies 

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

To apply please submit your CV. 

Candidates must be immediately eligible to work in Ireland, this is a site based role.

We are an equal opportunity employer and value diversity at our company.