Group Leader, Finished Products and Stability

Job description

Monitor and maintain the flow of work and schedule daily/weekly activities of staff Provide weekly, monthly or as required team updates to the Department Head. This includes safety reports, revenue reports, resource allocation summaries, improvement and new business opportunities, general concerns and any other business. With aid of Department Head, manage staff performance, personnel issues, concerns, etc. Manage resource allocation and project prioritization and work across groups and functions to manage resources efficiently.

Write, review, and approve protocols, drafts methods and technical reports. Participate in and lead investigations for OOS, OOT, and deviations. Participate and execute CAPA. Evaluate client requests, scope of work plans and provide customer proposals for their work. Write and review technical data, documents, SOPs and proposals as required. Executes experiments, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.

Keep all records and lab notebooks in good order. Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in timely manner. Coordinate method transfers between clients and SGS. In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate.

Maintain analyst and scientist work schedule and project plans in accordance with project timelines and key milestones. Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the QA reviewer.

Qualifications

BSc or MSc/PhD 5+ years in Chemistry or relevant field.

Experience testing with the following instrumentation

HPLC, GC, Dissolution, Thermometer, Oven 5+ years with demonstrated ability to complete more complex role/duties Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment. Demonstrated understanding of cGMP/GLP Ability to coordinate and manage a group and its workload. Ability to critically interpret and analyze data Able to read, understand, communicate and follow work instructions in a safe, accurate and timely manner.

Capable of interacting with all levels of management, suppliers and clients. Proven time management skills and a strong attention to detail. Extended hours and shift work may be required from time to time