1. To perform all routine functions associated with the establishment and maintenance of stability studies including:
Sample receipt and logging, monitoring of sample storage, management of sampling, withdrawal of samples as per stability schedules, coordination for analysis of samples, recording and reporting results using defined documentation systems.
2. To promptly report and investigate any adverse trends, deviations from expected results or documented procedures. To perform any trouble-shooting or investigative work on stability samples as may be directed by the Manager. To assist with investigations into abnormal test performance, stability trends or OOSs or manufacturing abnormalities, providing input to such working groups as necessary and advising on corrective/preventative actions.
3. To take responsibility for and deliver training and assessment on stabilities in support of colleagues and other departments.
4. To maintain and monitor controlled conditions of stability units, to ensure calibration status is in compliance with ICH limits. To monitor the cleaning, and maintenance of stability chambers equipment.
5. To initiate and direct documentation preparation, revision, review of standard operating procedures and assist with their introduction.
6. To assist with the identification and development of novel stability indicating methods.
7. To take full responsibility for the co-ordination and planning of stability protocols and to achieve successful completion of objectives and targets.
8. To generate written internal study reports as required, and to prepare reports for submission to regulatory authorities in support of licensing applications.
9. To attend meetings with senior staff from other departments, such as Production or R&D, to carry out periodic review of operations or stability requirements.
Salary: INR 1,75,000 - 3,50,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: R&D
Role: Formulation Scientist
Employment Type: Permanent Job, Full Time