Senior Officer/ Assistant Manager – R & D( Analytical/Formulation)
The White Horse Pharmaceuticals Ltd.
Job Responsibilities :
- 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) in M. Pharm
- The candidate should be an M.Pharm / B.Pharm with thesis in relevant R&D work.
Experience Requirements :
- At least 5 year(s)
- The applicants should have experience in the following area(s): Pharmacist
- The applicants should have experience in the following business area(s): Pharmaceuticals
Additional Requirements :
- Age 25 to 45 years
- Only males 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 :
- Provident fund
- Salary Review: Yearly
- The Successful Candidates will get oriented remuneration package and excellent working environment for rapid career growth.
How to Apply
Primary Information
Published on:
Vacancy:
Not specific
Employment Status:
Full-time
Gender:
Male
Age:
Age 25 to 45 years
Job Location:
Gazipur
Salary:
Negotiable
Application Deadline: