PurposeThe candidate shall have the role of analyst in analytical development lab to support pharmaceutical formulation development for Alternate Vendor/ANDA i.e., Liquid Oral /Solid Oral products. Along with analysis of Alternate Vendor he will also be responsible for Stability Management activities.
Position / Job TitleSr Executive
DepartmentAnalytical Department
Reporting ToAssistant General Manager
LocationThane
Years of Experience8-10 years
Dosage FormSolid Oral / Liquid Oral/Nasal/Ophthalmic/Injections
Job Responsibilities / DeliverablesJob Function
Development of stability indicating test methods and other methods as per the dosage form in line with regulatory requirements for Alternate Vendor/ANDA and smoothly transfer to analytical method validation team.
Provide inputs for development of analytical methods and perform analysis of finished product, Lab stability samples and compatibility study samples.
Evaluation of analytical results and correspondence with formulation departments
Preparevarious documents like Specs/STPs/protocols/AMDR.
Provide inputs for finalization of API, excipients, and finished product specifications.
Providing technical input based on different literature and available project documents.
Conduct development, stability studies as per the plan
Responsibility for Stability Management, managing the inward and outward movement of stability samples with proper documentation
Reviewing Stability Chamber Logs, records and environment monitoring data to ensure accuracy and compliance
Identifying and escalating any abnormalities or concerns related to Stability chambers along with timely follow up and coordination with Engineering team for resolution
Maintaining complete and up to date documentation, including Stability registers, logbooks and associated records
Preparation of SOP for New Stability Chamber, Retirement documentation.
Deliverables
Method development as per the timelines
Preparation of Analytical Method development Report
Preparation of Specification, STP and TTD documents
Method transfer to QC
Guidance to Junior team members
Raising PR and follow up with Supply Chain
Stability Management
Departments / Teams / Sub functions for Interaction on an ongoing basis.
FD, SCM, PMI, QC, DQA, CQA, IT, Eng
Qualifications & Pre-Requisites
Must-Have Skills:
- Knowledge of HPLC /GC/PSD/IR
- Exposure to various regulatory bodies
- Exposure to Solid oral dosage form, Suspensions, Solutions
- Knowledge of Stability Management
Additional notes
The candidate is expected to work in any shift as per requirement.
The candidate is expected to visit all sites of Rubicon for Method Transfer/ Investigations or as per requirement.
