Lead a client-based team of QC analysts to meet client requirements. 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
- 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
Key accountabilities as an analyst:
- Receive training from SGS and client and get qualified in relevant analytical techniques. Maintain own training 100% current. Train other analysts where appropriately qualified
- Carry out testing in accordance with the valid testing procedures and regulatory requirements
- Ensure that laboratory equipment is well maintained, and calibrations are carried out at the designated frequencies
- Manage inventory and status of materials required for analysis
- When qualified to do so, verify and review results generated by other analysts for compliance with requirements
- Ensure correct data entry to LIMS
- Assessment of testing results generated in the laboratory and close out of batch analysis
- Ensure that all target dates are met. Update visibility tools and communicate status of testing at meetings
- Maintain laboratories to a high housekeeping standard
- Ensure high standard of lab records, with work completed Right First Time and on time
- Write and maintain necessary documentation (SOPs, methods report etc)
- Work as part of the team ensuring customer expectations are met and exceeded. Support achievement of client and SGS Key Performance Indicators, such as around investigations, training, productivity and on-time testing
- Notify appropriate contact and document results and investigations for any atypical or aberrant results
- Lead Laboratory investigations and deviations if required
- Maintenance of a safe working environment, in a state of audit readiness
- Identification and implementation of safety, environmental, quality and service improvements
- Work with their leader to ensure self-development and progression