Stability Coordinator at HAL Allergy
The Stability Coordinator is responsible for the set up and maintenance of stability studies.
Ensures compliance of the studies to the relevant quality procedures and regulations.
Makes sure all products of HAL Allergy comply to registration regulations.
Tasks and Responsibilities
- Coordination of all aspects of GMP stability studies of our products.
- Initiates and reports stability studies with regard to changes and registration aspects, with compliance of the regulations.
- Coordinate the initiation of a stability study and responsible for timely analysis per time point (sample handling and documentation).
- Leads the stability meeting with the RA, Development, QC and QA departments.
- Responsible for the quality and regulatory compliance of stability procedures.
- Responsible for execution and reporting of ‘ongoing stability’.
- Initiates and coordinates expanding durability of our products, on the base of the results of the stability studies.
- Coordination, reporting and implementing stability assays.
- Maintain the sample inventory and related documentation according to GMP regulations.
- Prepare stability trend overviews and write stability reports to verify product shelf life and product expiration dates.
- Write and maintain stability and sample handling procedures.
- Initiate and write deviation reports, change control and CAPAs.
- Conduct continuous improvement projects related to quality and cost improvements related to stability studies.
- WO (biochemistry, molecular biology, biotechnology or similar) or HLO with additional experience.
- Preferably with more than 5 years of working experience in a similar position (similar type of work, with similar scope of tasks) within a cGMP (bio)pharmaceutical company working.
- Knowledge of English language, oral and written.
- Knowledge of MS-Office and relevant quality software, Q-Pulse and LIMS.
Personal & Professional Skills
- Strong knowledge of cGMP in relation to Quality Control.
- Strong coordination skills.
- Strong verbal and written communication skills in English.
- Able to convince by natural networking skills and strong presentation methods.
- Pro-active attitude.
- Thorough: ability to carry out tasks with an eye for completeness (e.g. studies achieved according to procedures /protocols).
- Self-organised: ability to focus and to plan accordingly and independently.
- Detail-oriented: analytical mind set, ability to pick up on important details.
- Problem solving: ability to identify problems (out of trend results, trends with equipment, or test results), discuss these within the team, and to find a solution.
- Co-operative: ability to work within a team and with other teams to drive projects forward according to agreed time lines.