We are looking for a candidatewith expertise in Method Development and Validation.
Responsible for the development and validation of analytical procedures used to analysedrug substances and drug products as well as the transfer of these proceduresto the various sites.
Responsible for re-evaluating, optimising andtroubleshooting methods as required by clients.
In additionresponsible for providing guidance to and overseeing analysts within theAnalytical Operations regarding the performance of their activities related todepartment.
Specific Responsibilities :
Perform the development and validation of analytical testing procedures for drug substances and drug products
Write protocols, drafts methods and technical reports for the Research and Development department and clients
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.
Write and Review technical data, documents, SOPs and proposals as required.
Coordinate method transfers between clients, the Research and Development group, and the RM / Finished Products departments
Assist in the failure investigations within other SGS groups and design investigation protocols and suggest corrective actions.
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.
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.
Participate in training sessions in the proposal, investigation and introduction of new technologies and services for SGS
Ensure that equipment is maintained properly. Also perform calibrations and qualifications as required.
Oversee, train, mentor and guide Analysts / Scientists in their work
Perform other assigned lab duties as requested.
Required Education, Skills and Abilities :
Education : MSc / PhD
Experience : 5+ years with demonstrated ability to complete more complex role / duties as mentioned above.
Must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
Demonstrates excellent verbal and written communication skills.
Ability to work well with others & independently.
Proven time management skills and a strong attention to detail.
Additional Information :
SGS Canada is an equal opportunity employer and we are committed toachieving greater accessibility by providing accommodation for people withdisabilities during our hiring process.
Accommodations are available on request for qualified candidates duringeach stage of the recruitment process.
Please note that candidates applying for Canadian job openings should beauthorized to work in Canada.