The Stability Specialist performs operations related to stability studies and programs, ULIS/LIMS operations related to the stability program, communication with clients (written and oral), coordination with the various Neopharm departments regarding study creation/modification/protocols/stability specifications, and sample management in the stability chambers. The Stability Specialist makes sure that all work is done and documented in accordance with good manufacturing practices and standard operating procedures.
- Ensure stability operations function smoothly;
- Help prepare stability submissions for customers managed by the stability department by communicating with the customer and the other departments using the appropriate tools and software;
- Write stability related protocols and reports;
- Initiate stability studies in the ULIS/LIMS computer system once samples are received;
- Label the samples and place them in the appropriate environmental conditions;
- Remove the test samples from storage according to the protocol or procedure;
- Prepare samples for analysis with LIMS software, using both internal documentation, customer documentation and the appropriate labels for different laboratory tests;
- Make sure that tests are conducted using the correct methods and that the scheduled tests are performed correctly according to the protocol at each point of stability in LIMS;
- Resolve any laboratory issues that may arise regarding the stability specifications and documentation;
- Manage the stability program invoicing processes through LIMS and make the connections between the LIMS/ULIS software programs;
- Proactively coordinate and manage telephone, email or in-person requests regarding stability projects and issues between clients, laboratories, operations, finances, quality assurance and customer service, ensuring internal and external customer satisfaction;
- Write stability related change controls, deviations and CAPAs and make the necessary changes;
- Perform all the steps required for photostability studies, transport studies and freeze-thaw testing;
- Attend and organize meetings with the departments concerned to suggest solutions and ensure accurate and timely monitoring to enhance image and service;
- Perform data entry for clients and data extrapolation according to the ICH guidelines;
- Prepare stability samples for shipping with the attached documentation;
- Be on call and available to go on site on nights and weekends to manage stability chambers in case of excursions;
- Be responsible for speaking with clients regarding all situations (submission, audit, study review, etc.);
- Respect the quality system by performing tasks related to the stability programs;
- Report any encountered problems to the immediate supervisor;
- Any other related tasks.
- DEC/BSc. In Chemistry or Biochemistry;
- Have the knowledge required for AQPIC qualification;
- Have a good understanding of the ICH, FDA, WHO, EMEA and USP/EP stability guides;
- Have three years of experience in the pharmaceutical industry;
- Understanding of French and written English;
- Good concentration and attention to detail;
- Availability and flexibility;
- Understand technical details and be very comfortable communicating details to internal and external customers;
- Excellent time-management skills and the ability to meet tight deadlines.
- Ability to work in a computing environment.