QC Laboratory Manager

Job Purpose
Responsibility for the efficient day to day management of the Quality Control laboratory and QC analysts at TPIN including:

1. Routine testing and approval of raw materials, packaging materials, Active Pharmaceutical Ingredients (APIs), finished dosage tablets in accordance to quality and EHS systems.
2. Stability studies in accordance to ICH guidelines.
3. Equipment maintenance and calibration in line with GXP guidelines.

 
Organisation
This position has direct line management responsibilities.

 Main Areas of Responsibility

1. Responsibility for all analytical staff working within the Quality Control laboratory (QC).
2. Management of QC analyst workload & priorities ensuring work tasks are performed in an efficient manner according to the needs of Production and Commercial departments.
3. Ensure analysts are trained and work in accordance to EHS and quality systems and procedures.
4. Maintenance, calibration and qualification of analytical instruments in QC.
5. Testing & approval of raw materials, packaging materials, APIs and finished products (tablets) against pre-defined specifications.
6. Responsibility for overall management of API and finished product stability studies including servicing of stability cabinets, maintenance of databases and preparation of annual stability PQR reports.
7. Manage the handling of out of specification (OOS) and non-conformance handling relating to QC instrumentation and testing of raw materials, packaging materials, APIs and finished dosage forms.
8. Contribute to the definition, reporting and measuring of KPI's for the QC.
9. Identify opportunities for continuous improvement in QC, in collaboration with other departments, focusing on HSE, quality, efficiency and control of costs.
10. Assist in trouble shooting of analytical issues within QC (e.g. degradation and impurities in finished products / DC / API).
11. Work in collaboration with Process Development in the development and validation of analytical methods to support new API product development and commercialisation (IPC, release and stability methods).
12. Contribute to the preparation of Pharmaceutical / Chemical Registration documentation for finished products and APIs, for changes to an existing product and possibly for new API products.
13. Prepare / approve quality specifications and methods for raw materials, APIs and finished products.
14. Control of the revenue budget for QC.
15. Maintain pharmacopoeia methods in line with current regulations.
16. Management of customer, third party and regulatory audits in QC.
17. Assist in the investigation of customer complaints relating to site production including the necessary reporting, communication and corrective actions, where applicable. 

Budgetary Control
Control of departmental expense budgets.
 
Key Skills
QC experience within a Pharmaceutical business.
Line-management experience.
Analytical Chemistry experience.
Experience of working within a GMP environment.
Life-Science degree or equivalent.
 
For more information about this position, please contact Annemieke Nesse, Branch Manager Kelly Scientific Resources at +47 92208761