BUSINESS: Piramal Pharma Solutions
DEPARTMENT: Quality Control
LOCATION: Grangemouth
Job Overview:-
To supervise and execute defined and trained Quality Control department tests for the release of raw materials, in process products, bulk drug substance, final products and stability products according to defined procedures and proctocols and according with best cGMP work practices, Quality standards and metrics.
Reporting Structure:-
Reports to QC Team Leader (Clinical ADC)
Key Roles/Responsibilities:
1. Execute analytical procedures, for testing of raw materials, in process products, bulk drug substance, final products and stability products according to defined by SOP´s, and protocols and ensure that the QC team is in compliance with the same.
2. Apply best cGMP work-practices and techniques to test and release raw materials, in process products, bulk drug substance, final products and stability products within specification
3. Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
4. Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the QC Analysts
5. Immediately escalate and report any deviations to materials, facilities, processes or procedures to the QC Manager
6. Be accountable for the analytical laboratories being clean, tidy and well organized and in a state of continuous inspection readiness.
7. Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements
8. Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
9. Issue, manage and close-out deviations, change controls, OOS or SST investigations and CAPA´s in a timely fashion
10. Identify areas for continuous improvement and escalate those to the QC Manager.
11. Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
12. Support installation, qualification and periodic review of equipment.
13. Support the transfer of new methods and techniques into Quality Control.
14. To undertake any other duties as requested by the line manager in accordance with company requirements.