Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Responsibilities:
1. This is a 12-M contracted replacement for an employee on leave.
2. A customer facing role as QC representative for specific projects. Present QC scope to the client in kick-off meetings. Independently liaise with clients regarding standard work scope. Confidently handle client queries, expectations, and challenges. Support overall QC planning by supplying and updating relevant dates as agreed in the project team.
3. Author QC specific batch documentation including Sampling Plans, specification documents, qualification and validation protocols and reports in line with Patheon policies and regulatory guidelines. Review protocols, data, and reports.
4. Prepare data in support of specification discussions and facilitate specification council meetings.
5. Investigate and evaluate new methods/techniques, judge their scientific soundness, and decide on the feasibility of implementation at the Patheon Brisbane site.
6.Independently initiate and handle change control activities ensuring adherence to cGMP and EH&S guidelines.
7. Liaise with QC laboratory teams to draft test methods. Support QC laboratory teams in developing relevant test methods for use. Assist QC laboratory team members with execution of analytical studies and troubleshooting method performance where relevant.
8. Work directly with the program management teams to ensure analytical contractual stages and timelines for customer projects are met.
9. Work directly with the program management team to ensure customer satisfaction and expectations are maintained in the most profitable way.
10. Monitor new technologies that are relevant to the QC department, which may offer a more cost effective and robust solution to the business.
11. Ensure the scientific integrity of the QC teams is maintained, working closely with the data integrity officer.
12. Facilitate atypical, out of specification or out of trend investigations with the team to ensure swift resolution, recommending appropriate resolution.
13. Practical application of various risk assessments tools (i.e., failure mode effect analysis, fishbone diagrams, hazard, and operability studies) and ability to directly develop, participate, and advise others on the appropriate and efficient application of these processes.
14. Practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.
15. Assist with PPI projects.
16. Perform any other legitimate duties as directed by the Senior Manager, QC (or delegate).
Requirements:
1. Have 3-5 years of GMP experience;
2. Have client-facing experiences, able to confidently manage client's expectations;
3. Have strong analytical skills and analytical document (such as protocols and reports) writing experience ;
4. Good at communication in-person, via teleconferences, and through e-mails.
5. Attend to details and able to work in fast-paced environment.