- To Execute Analytical Method Development activities of drug products under
- development, based on QbD principles and regulatory requirements.
- Execution of Analytical Method validation activities for drug products as per the
- regulatory requirements.
- Execute routine Analytical Research activities of drug products.
- Establishing In-house systems and procedures to ensure cGLP practices &
- regulatory requirements for analytical activities at in-house R & D Facilities.
- Profile Description & Ability:
- Strong conceptual, analytical development and validation skills.
- Good communication (verbal, writing) and presentation skills.
- Must have ability to work under pressure, meet deadlines, and work on multiple
- projects simultaneously.
- Must be a team player and be able to interact with staff at all levels of the
- company and with external parties as well.
- Must have ability to work independently.
- Adequate Job knowledge and exposure to different Analytical methods and
- instrumentations.
- Adequate Job knowledge and exposure to QbD, DoE and statistical
- interpretation etc.,
- Trouble shooting related to Testing methods, Stability studies, test results and
- designing of additional
- experimentations as necessary
- Execution & coordination for Analytical method transfer activities of drug
- products.
- Calibration of the Analytical instruments as per the master calibration schedule.
- Technical assessment & Analysis of drug substances (API) for projects execution.
- Review & clearance of technical documents leading to dossier batches
- executions and registrations.
- Preparation and review of Specifications, Method of analysis procedures and
- Analytical development
- reports.
- Preparation and review of analytical protocols and reports (Analytical method
- validation, Method
- feasibility, Analytical method transfer, etc.).
- Technical assessments of projects (Screening, pipeline and development projects
- stages) & Literature
- search).
- Preparation of analytical technical documents for dossier / Technology transfer
- executions / Regulatory
- submissions of projects.
- Assisting and resolving technical queries raised during Technology transfer
- activities & regulatory .
- submissions.
- Assisting in establishment of In-house Infrastructure (Analytical equipment's
- Qualifications and preparation of SOP's).
- Assessment & coordination on regulatory deficiencies.
- Assisting with analytical requirements in finalization of project costings.
Educational Requirements :
- Master of Pharmacy (M.Pharm)
- The candidate should be an M.Pharm / B.Pharm with a thesis in relevant R&D work.
Experience Requirements :
- 5 to 7 year(s)
- The applicants should have experience in the following area(s):
Pharmaceuticals, Pharmacist
Additional Requirements :
- Age 25 to 35 years
- Both males and females are allowed to apply
- Candidates who are applying for the senior officer post should have working experience as officer at least 03 years.
- Candidates who are applying for the Assistant Manager post should have working experience as senior officer at least 03 years.
Compensation & Other Benefits :